Surgical Navigation Systems

Centerline Biomedical develops intraoperative navigation technology for endovascular and interventional procedures. The company's flagship product, IOPS® (Intra-Operative Positioning System), is a 510(k)-cleared navigation platform that provides real-time 3D color image guidance as an alternative to conventional X-ray fluoroscopy. IOPS® is designed to mitigate occupational and patient radiation exposure in interventional cardiology, vascular surgery, and complex endovascular procedures. The system offers interactive navigation, high-quality 3D imaging, and portability compared to traditional 2D fluoroscopy-based guidance. Clinical evidence presented on the site documents significant occupational hazards associated with fluoroscopy exposure, including radiation-induced cataracts, brain tumors, and orthopedic issues among interventionalists. IOPS® targets procedures estimated at 4 million annually in the United States. The company collaborates with major medical institutions including Cleveland Clinic, the U.S. Air Force 59th Medical Wing, and the U.S. Army Institute of Surgical Research, indicating validation in both civilian and military surgical settings. The technology is positioned for vascular surgeons, interventional cardiologists, and trauma surgeons performing endovascular therapy, aortic procedures, and complex case management where radiation dose is a clinical and occupational concern.

SentiAR, Inc. develops holographic augmented reality (AR) and mixed reality software solutions for minimally-invasive interventional procedures, primarily in cardiology and electrophysiology. The company's flagship product, CommandEP, creates interactive 3D visualizations in real-time by integrating data from cardiac catheters and 3D electroanatomic mapping systems to display cardiac anatomy during interventional procedures. The system provides physicians with a 360-degree, interactive view of treatment delivery while maintaining sterile conditions—operators control the display via gesture-based interfaces without direct contact. CommandEP is designed for electrophysiologists, cardiologists, radiologists, and anesthetists performing catheter-based interventions. The technology addresses limitations of current imaging and visualization workflows by consolidating multiple data sources into a unified 3D representation, improving procedural accuracy, efficiency, training, and patient communication. SentiAR's AR platform enables real-time guidance during complex interventions, supports peer and resident education, and facilitates post-procedure patient explanation through holographic visualization. The company markets its solutions to interventional centers, cardiac catheterization laboratories, and teaching institutions seeking to enhance procedural precision and outcomes in minimally-invasive cardiology.

Thompson Surgical Instruments, Inc. is a USA-based manufacturer of surgical retraction systems with over 55 years of hands-free retraction innovation. The company specializes in table-mounted retractor frames designed to reduce surgeon fatigue, decrease OR staffing requirements, and minimize surgical duration. Thompson's product line features low-profile, radiolucent retraction systems engineered for stability and consistent exposure across multiple surgical disciplines. Their proprietary frame design accommodates various surgical applications including general abdominal, liver oncology, and cervical procedures. The retractors are built with unparalleled stability to resist slippage and flex under heavy intraoperative force. Thompson emphasizes direct surgeon control, improved line of sight, and hands-free operation to streamline surgical workflow. All products are manufactured in the USA with commitment to service and support. The company serves surgical centers and hospitals requiring reliable, specialized retraction solutions for open abdominal and cervical procedures.

Mendaera develops the Focalist™ handheld robotic system, a breakthrough medical device that combines robotics with real-time ultrasound imaging to enhance needle-based clinical procedures. The system is designed to improve clinician precision and confidence during interventional ultrasound-guided procedures by providing automated targeting and trajectory visualization. The Focalist system integrates two core technologies: a handheld robotic component that stabilizes and guides needle placement, and real-time ultrasound imaging with target trajectory visualization. This combination addresses the complexity and skill requirements of traditional ultrasound-guided needle procedures, enabling clinicians to perform interventions with greater accuracy. Mendaera received FDA clearance for the Focalist system and is preparing for broad commercial launch in 2026. The company targets healthcare providers performing needle-based interventions across multiple clinical specialties. The device represents a significant advancement in image-guided surgery and interventional medicine, addressing a critical gap in procedural precision and operator-dependent variability.

Forj Medical is a global contract design and manufacturing organization (CDMO) specializing in advanced medical device development and high-volume manufacturing. The company operates 450,000+ square feet of manufacturing space across six global facilities (U.S., Costa Rica, Singapore, Indonesia) and assembles 250+ million devices and components annually. Core competencies include electromagnetic sensors and navigation systems, surgical energy systems, fluid and gas management solutions, optical systems, stimulation and active wearables, and consumables and components. Forj Medical provides end-to-end services from concept and full medical device system development through commercialization, including custom electromechanical system design, design for manufacturing (DFM), design for automation and scale, custom prototyping, and process and test development. Manufacturing capabilities are vertically integrated, encompassing PCBA manufacturing, precision molding, cable assembly, cleanroom operations, polymer and metal 3D printing, and automation. The company maintains ISO 13485 certification and holds five FDA Establishment Registrations. Quality management systems include robust QMS, traceability protocols, risk management, and audit readiness. Supply chain and operational services include supply chain management, service and maintenance, sustaining engineering, packaging and shipping, and international logistics. Clients span Fortune 500 medical device manufacturers and emerging medtech companies. The organization combines 4+ million combined hours of medical device engineering expertise across its portfolio.

SURGLASSES Inc. (Taiwan Main Orthopaedic Biotechnology Co., Ltd.) is a medical technology manufacturer specializing in augmented reality (AR) surgical guidance systems for orthopedic and neurosurgery applications. The company develops computer-assisted surgical navigation platforms designed to reduce X-ray radiation exposure, improve surgical precision, and enable minimally invasive procedures. Core product lines include the Caduceus S AR Navigation System (FDA 510(k) cleared in December 2022), a spine 3D computer surgery navigation system, and surgical planning software. The company also manufactures medical education platforms, including the Asclepius Virtual Dissection Table (available in multiple sizes for institutional use) and the Asclepius AI Table, described as the world's first AI-powered anatomy table featuring integrated modules for anatomy, radiology, histopathology atlas, and CT rendering. The Asclepius platform supports online examination and anatomy app functionality for medical schools and training institutions. SURGLASSES holds FDA 510(k) clearance and serves hospitals, physicians, and patients across North America and Asia-Pacific markets. The company reports completion of the first AR surgery procedure in the United States (April 2023). Operations include manufacturing and distribution facilities in Taiwan and the United States, with focus on reducing surgical time, improving outcomes, and lowering procedural costs through advanced visualization and navigation technologies.

Highridge Medical is a global medical device company specializing in innovative spinal solutions and motion preservation technologies. Established in 2024 following H.I.G. Capital's acquisition of the Spine and EBI businesses from ZimVie, the company develops comprehensive spine surgical portfolios including cervical and lumbar disc replacement systems, deformity fixation platforms, interbody fusion devices, and vertebral body tethering systems. Highridge's product line features the Mobi-C® Cervical Disc, the upcoming activL® Lumbar Disc (launching July 2025), the Vital™ Navigation System for open and minimally invasive procedures, and additional fixation and fusion solutions. The company emphasizes surgeon-driven design, clinical research and development, and medical education to advance spine care outcomes. Leadership includes Executive Chairman Eric Major and CEO Rebecca Whitney, with a commitment to advancing patient mobility and strength through accountable, compassionate partnerships with healthcare providers.

OrthAlign, Inc manufactures surgical navigation and alignment technology for orthopedic joint replacement procedures. The company's primary product platform is Lantern®, a handheld navigation system designed to improve precision and efficiency in total hip arthroplasty (THA), total knee arthroplasty (TKA), revision knee procedures, and partial knee arthroplasty (PKA). Lantern Hip and Lantern Knee are modular product lines that enable surgeons to perform joint replacements with enhanced accuracy in various surgical settings, including ambulatory surgery centers (ASCs), hospital operating rooms, and outpatient facilities. The technology is characterized as simple and efficient, designed to work with any surgeon and any OR setup without requiring specialized infrastructure. OrthAlign positions its offerings for the growing outpatient joint replacement market, emphasizing accessibility and ease of adoption across diverse surgical environments. The company maintains a surgeon finder tool to help patients locate practitioners using OrthAlign technology. While specific regulatory certifications are not detailed in the available content, orthopedic surgical navigation systems typically require FDA 510(k) clearance for US distribution. The company's focus on ASC compatibility and surgeon accessibility suggests a market strategy targeting both high-volume academic centers and emerging outpatient surgical venues.

Enhatch is an AI-powered medical software platform specializing in preoperative surgical planning for orthopedic and spine surgeries. Founded in 2012 and based in Hasbrouck Heights, New Jersey, the company provides the Intelligent Surgery Ecosystem and Intelligent Surgery Platform—cloud-based solutions that automate 3D surgical case planning from 2D medical imaging (DICOM). The platform streamlines patient-specific surgical workflows for medical device manufacturers, hospitals, surgeons, and orthopedic distributors. Key capabilities include automated 3D model generation, real-time case tracking, multi-stakeholder collaboration portals, role-based access controls, and seamless integration with 3D Systems for additive manufacturing of personalized implants and surgical instruments. Enhatch's solution reduces surgical planning cycles, enhances remote collaboration, and enables point-of-care manufacturing. The company maintains FDA clearance and has achieved SOC 2 Type II, HIPAA, and HITECH compliance certifications, serving major OEM partners including DePuy Synthes, Enovis, and Curiteva.

Eigen Health is a California-founded medical technology company (established 1975) specializing in advanced MRI-ultrasound fusion systems and minimally invasive focal therapies for prostate cancer diagnosis and treatment. The company operates in 36+ countries, serving academic institutions, hospitals, and clinical practices globally. The Artemis platform is their flagship 3D semi-robotic prostate biopsy system featuring real-time organ tracking and prospective needle navigation with switchable transrectal and transperineal modules. It performs rigid and elastic registration of multimodal imaging (MRI, PET-CT, PSMA PET-MRI) to real-time ultrasound. The TPO (Transperineal Operative) module is purpose-built for transperineal approaches with integrated ultrasound capabilities. ProFuse CAD is their advanced radiology software for computer-assisted detection, real-time mpMRI analysis, and MRI data preparation for fusion guidance. The Cryo product combines MRI/ultrasound fusion-guided biopsy with cryoablation for minimally invasive, often outpatient prostate cancer treatment. The company reports supporting clinical outcomes for over 3,000,000 patients worldwide and maintains multiple patents in fusion imaging and needle guidance technology. ISO 13485 certified, indicating compliance with medical device quality management standards. The company emphasizes long-term partnerships with distributors and clinical institutions for seamless technology integration into practice and research.

ClaroNav Inc. is a Toronto-based surgical navigation company founded in 2001, specializing in precision, portable, and affordable image-guided surgical systems for dental, ENT, and neurosurgery applications. The company develops advanced optical navigation systems utilizing CT and MRI imaging to enhance procedural accuracy and patient outcomes. ClaroNav's flagship dental products—Navident EVO for dynamic implant navigation and MicronMapper EVO for restoration with photogrammetry—deliver real-time guidance with superior restoration accuracy. For general surgery, Navient provides a truly portable, cart-based image-guided navigation system featuring intuitive software, steam-sterilizable instruments, and zero disposable costs per procedure. Additionally, ClaroNav licenses and customizes its proprietary MicronTracker optical tracking technology and navigation applications to OEM partners, enabling rapid integration of surgical navigation into third-party platforms. The company serves dental surgeons, ENT specialists, and neurosurgeons with clinically validated, cost-effective solutions.

Proprio manufactures Paradigm™, an FDA-cleared surgical navigation and AI guidance platform designed for intraoperative spinal surgery applications. Paradigm combines advanced sensors, computer vision, and light-field imaging to deliver real-time 3D anatomical visualization and measurement without ionizing radiation. The platform performs continuous segmental registration, adapting automatically as patient position, table, and surgical field change—eliminating the need for repeated intraoperative imaging. Key capabilities include on-demand radiation-free measurements of spinal alignment, disc height, and segmental angles; implant-agnostic guidance; and passive collection of structured surgical data throughout preoperative, intraoperative, and postoperative phases. Clinical data show approximately 1+ hour saved per surgery, 30% increase in reimbursements, 3-4x decrease in revision surgeries, and 10x reduction in radiation exposure. Proprio has received multiple FDA 510(k) clearances, including a third clearance for dynamic 3D segmental viewing. The platform generates standardized data enabling longitudinal learning across hospital systems, objective case documentation, training initiatives, and quality programs. Proprietary AI models, trained on cases from hundreds of surgeons, enable continuous system learning. Paradigm is designed to reduce reliance on intraoperative 3D imaging and mobile CT, potentially lowering long-term capital planning costs while optimizing surgical workflows and improving institutional surgical performance metrics.

Specto Medical AG is a Swiss medtech software company founded in 2022 as a spin-off from the University of Basel. The company specializes in real-time 3D visualization software that converts CT and MRI scans into immersive virtual reality (VR) and augmented reality (AR) experiences. The platform transforms traditional 2D medical imaging into interactive 3D anatomical models, enabling surgeons and clinicians to gain instant spatial understanding of complex anatomical structures before, during, and after surgical procedures. The software supports clinical decision-making, patient education, and surgical planning with FDA clearance and full CE certification. Primary applications include cranial neurosurgery, brain aneurysm and tumor procedures, and complex anatomical case planning. The company offers seamless DICOM integration and volume rendering technology with lightning-fast processing times and anatomically accurate visualizations.

DeGen Medical is a medical device development and manufacturing company founded in 2011, specializing in innovative spinal care solutions for complex spinal disorders. The company develops advanced spinal implants and instrumentation using cutting-edge technologies including AI-driven augmented reality platforms and proprietary 3D printing processes. Their product portfolio includes the Solar AM anterior lumbar interbody fusion (ALIF) device and instrumentation designed for both open and minimally invasive spine surgeries. DeGen Medical serves orthopedic surgeons and surgical centers, targeting conditions such as vertebral compression fractures and motion preservation. The company combines clinical insights with advanced biomedical engineering to deliver world-class implants and patient-specific solutions that improve surgical precision and patient outcomes.

Perimeter Medical Imaging AI is a medical technology company specializing in intraoperative optical coherence tomography (OCT) imaging systems enhanced with artificial intelligence for cancer surgery guidance. The company's FDA-cleared Perimeter S-Series OCT and next-generation B-Series OCT with ImgAssist AI software provide real-time, cellular-level margin visualization during breast-conserving surgery and other oncologic procedures. These systems enable surgeons to identify residual tumor tissue and assess surgical margins with unprecedented clarity, reducing re-excision rates and repeat surgeries. Perimeter's technology leverages advanced optical imaging and machine learning algorithms to deliver actionable intraoperative insights, helping surgical teams close with confidence while improving patient outcomes and lowering healthcare costs. The company operates from Dallas, Texas with headquarters in Toronto, Canada.

eCential Robotics is a surgical robotics company specializing in an open, unified platform integrating 2D/3D imaging, real-time navigation, and robotic systems for bone surgery. Founded in 2009 and headquartered in Grenoble, France, with US operations in Franklin, Tennessee, the company serves orthopedic and neurosurgery markets with over 3,500 completed procedures. The platform is implant-agnostic, supporting third-party surgical app development and compatible with implants from multiple manufacturers, allowing surgeons to select the optimal technique and device for each patient. Key features include integrated imaging and navigation within a single interface, support for minimally invasive approaches, and multi-specialty surgical applications. With over 100 patents and approximately 105 employees, eCential Robotics focuses on digitalizing traditional surgical techniques to enhance patient safety, surgeon precision, and operational efficiency in the OR.

Activ Surgical is a Boston-based digital surgery company specializing in hardware-agnostic surgical software and intraoperative imaging technologies designed to enhance visualization and reduce surgical errors. The company's flagship product, ActivSight™ Intelligent Light, is FDA-cleared and integrates with existing laparoscopic and robotic surgical systems to provide real-time visualization of blood flow and tissue perfusion. ActivSight offers surgeons critical physiological insights invisible to the naked eye through dye-free ActivPerfusion™ and ActivICG™ imaging modes. The patent-protected ActiveEdge™ platform leverages augmented reality, artificial intelligence, and machine learning to improve intraoperative decision-making and address preventable surgical complications. Activ Surgical has achieved significant milestones including the world's first autonomous robotic surgery of soft tissue and CE Mark approval. With $87.5 million in funding, the company operates pilot sites in major U.S. hospital networks, addressing the critical clinical need that preventable surgical errors contribute to over 400,000 deaths annually in the U.S.

IMRIS is a global leader in intraoperative MRI imaging solutions, specializing in fully integrated hybrid operating suites for image-guided neurosurgery. Founded in 2005 from research at Canada's National Research Council and headquartered in Chaska, Minnesota, IMRIS designs, manufactures, and deploys movable intraoperative MRI systems that enable real-time imaging during surgical procedures without patient relocation. The flagship product, the IMRIS Surgical Theatre, features a ceiling-mounted rail system that transports the MRI scanner between a diagnostic imaging room and adjacent operating rooms, bringing imaging directly to the surgical field. This innovation enhances precision in minimally invasive neurosurgical interventions and has benefited over 70,000 patients worldwide across more than 100 hospitals and cancer centers. The company holds 30 patents related to MRI-guided procedures and provides comprehensive services including customized surgical suite design, installation, clinical training, and ongoing support. IMRIS also offers image-guided surgical robotics and works in partnership with industry leaders to deliver integrated intraoperative imaging products.

Optosurgical is an early-stage medical device company developing intraoperative imaging technologies to enhance surgical safety and precision. The company specializes in fluorescence-guided surgery systems that deliver real-time structural and functional tissue visualization to surgeons. Their flagship product, hANDY-i, is a hand-held imaging device designed to prevent parathyroid gland damage during thyroid removal surgery without requiring contrast agents. The company also develops 3DMAV (3D Multi-Angle-View) technology for single-lens systems and advanced visualization solutions for biliary and other complex abdominal surgeries. Optosurgical's mission is to make critical anatomy visible intraoperatively, reducing operative time and improving surgical outcomes across thyroid, bile duct, and other complex procedural domains.

nView medical develops intraoperative 3D imaging and surgical navigation systems designed to enhance safety, speed, and accuracy in operating room procedures. The company's flagship product, the nView s1™, combines low-dose 3D imaging capture with true-map navigation™—a GPS-like surgical guidance system that uses real anatomical images as navigation maps. The system integrates imaging, tracking, and AI technologies to provide surgeons with intraoperative planning, real-time guidance, and quality control capabilities. Originally developed for pediatric surgery, the nView s1 has expanded into adult spine surgery applications. The platform is FDA 510(k) cleared and has been deployed in leading pediatric institutions including Scottish Rite for Children and St. Louis Children's Hospital. As of March 2025, nView medical has completed over 500 surgical procedures. The management team brings extensive experience from GE Healthcare in imaging and navigation technologies. The company pursues partnerships with established medical device organizations, including a strategic investment and partnership with Orthofix announced in January 2022.

UltraGreen.ai is a global leader in fluorescence-guided surgery and surgical intelligence solutions. The company develops an integrated ecosystem combining indocyanine green (ICG) fluorescence pharmaceuticals, near-infrared imaging hardware, AI-powered quantification software, and cloud-based data analytics platforms for real-time surgical decision-making. UltraGreen's technology stack includes IC-Green®/Verdye™ (indocyanine green), IC-Flow™ compact handheld NIR cameras, PerfusionWorks™ AI-driven quantification software, and UltraGreen Data Systems cloud platform for capturing and analyzing surgical outcomes. Approved and distributed in 28+ countries with regulatory exemptions in 40+ markets, the company serves surgeons across general surgery, vascular, oncology, and other specialties, with operations spanning North America, Europe, and Southeast Asia.

Mitaka USA, Inc. is a medical technology manufacturer founded in 1997, specializing in advanced optical, electronic, fluorescence, microscopic, and 3D imaging devices for microsurgery. Headquartered in Wheat Ridge, Colorado, the company develops high-precision surgical visualization and instrumentation tools targeting ENT, neurosurgery, plastic surgery, hand surgery, spine, and wound care specialties. The product portfolio includes the MM77, MM90, MM80 SS1, and MM51 microscopy systems featuring integrated fluorescence imaging and ICG (indocyanine green) detection for real-time tissue visualization during minimally invasive procedures. Complementary offerings include the UniARM surgical arm positioning system, EMI Instruments (Supermicro microsurgical instruments), HawkSight imaging enhancement, Crownjun Suture materials, and Pero-System limb volume measurement technology. Mitaka also provides WetLab training vessels and comprehensive surgeon training programs to support professional development across multiple surgical disciplines. The company emphasizes agile product development, responsive customer service, and precision engineering to enhance surgical performance and patient outcomes.

Waypoint Orthopedics is a spine surgery medical device company founded by Dr. Stephen Banco and backed by Runway Healthcare, LP. The company specializes in vertebral fixation systems designed to reduce radiation exposure and enhance surgical efficiency in open and minimally invasive spine procedures. Waypoint's primary product is the GPS (Guided Pedicle System), an FDA-approved surgical navigation system that provides real-time intraoperative guidance for pedicle screw placement. The system addresses a critical occupational health concern: spine surgeons routinely exceed their lifetime radiation exposure limits within the first decade of practice, experiencing up to 12 times higher radiation exposure than other fluoroscopically-assisted surgical specialties. The GPS system enables more confident pedicle screw positioning while substantially reducing radiation exposure to surgeons, operating room staff, and patients. The company's regulatory credentials include FDA approval for use in both open and minimally invasive spine (MIS) surgery. Leadership includes seasoned medtech executives, with clinical guidance from a surgeon advisory board comprising experienced spine surgeons. Waypoint targets hospital and ambulatory surgical center OR environments performing routine spinal fusion and stabilization procedures. The company positions its technology at a large addressable market—approximately 1.62 million spine surgeries annually in the United States—where pedicle screw fixation is a standard technique.

Brainlab is a Munich-headquartered medical technology company specializing in digital surgical ecosystems, robotic-assisted surgery, and intraoperative imaging platforms. The company designs integrated software and hardware solutions for neurosurgery, orthopedic spine surgery, radiosurgery, and craniomaxillofacial procedures. Core product lines include the Brainlab Robotic Suite (robotic-assisted surgical systems), Loop-X (mobile robotic intraoperative CBCT imaging), Spine Mixed Reality Navigation, spinal planning software, Elements (radiosurgery planning and automation), and Craniomaxillofacial Planning software. Brainlab also manufactures surgical navigation systems, mixed-reality visualization platforms, and ultrasound-based intraoperative guidance tools. The company markets solutions globally to hospitals and surgical centers, supporting minimally invasive and open procedures. Regulatory credentials include CE marking and FDA clearances; the site references 510(k) submissions and compliance with international standards. Brainlab operates worldwide with headquarters in Munich-Riem, Germany, and maintains regional presence across North America, Europe, and Asia-Pacific. The company emphasizes end-to-end surgical ecosystem integration, enabling preoperative planning through intraoperative execution and has partnerships with academic medical centers and large health systems.

Ziehm Imaging GmbH is a Germany-based manufacturer of intraoperative mobile C-arm imaging systems and related software solutions for surgical guidance and case planning. The company's core product portfolio includes mobile C-arm fluoroscopy systems (Ziehm Vision RFD 3D, Ziehm Vision RFD Hybrid Edition, Ziehm Vision FD, Ziehm Solo FD) designed for orthopedic, vascular, cardiac, and general surgical applications. Ziehm operates through subsidiaries including Therenva SAS, which develops advanced planning and navigation software (EndoSize for preoperative planning, EndoNaut for intraoperative vascular navigation with image fusion). Key differentiator: SmartDose technology for dose-optimized imaging. Products deliver real-time fluoroscopic guidance with emphasis on dose reduction and image quality. Systems support 2D and 3D imaging, video endoscopy integration, and intraoperative image fusion with preoperative CT/MR data. Ziehm serves orthopedic, hand surgery, vascular/endovascular, cardiac intervention, and interventional pulmonology markets globally. US operations headquartered in Orlando, FL with nationwide service network. Company exhibits at major surgical conferences (FESSH, Charing Cross, CX Symposium) and publishes clinical evidence and case studies. CE-marked and FDA-cleared devices. Global distribution through network of regional partners and direct sales.

Circinus Medical Technology (operating as Bolt Navigation) designs and manufactures the Bolt Navigation System, a handheld, surgeon-controlled surgical navigation device for spine surgery. The system employs gyroscope-on-chip technology to provide accurate real-time guidance for pedicle screw placement and other spinal instrumentation procedures. Unlike conventional navigation platforms requiring expensive capital equipment, extensive imaging, or technician support, Bolt integrates seamlessly into existing OR workflows with minimal setup and zero footprint. The device is implant-agnostic, reducing radiation exposure for surgeon and patient while eliminating the need for preoperative registration or external imaging. Bolt operates on a flexible subscription model rather than capital purchase, making it particularly accessible to ambulatory surgery centers (ASCs). The system is designed to enhance surgical accuracy, improve workflow efficiency, reduce operative time, and lower total cost of ownership. The company targets surgeons and surgical teams across hospital systems and ASCs seeking radiation-reduced, cost-effective navigation without major infrastructure investment.

Intellijoint Surgical is a Canadian medical technology company that develops and commercializes surgical navigation solutions for total joint replacements, including hip and knee arthroplasty. The company provides both pre-operative planning software and intraoperative navigation systems designed to improve surgical accuracy, reduce outliers, and enhance patient outcomes. Intellijoint VIEW is a web-based surgical planning platform that enables functional cup planning, implant templating, and coronal alignment planning without requiring CT imaging, with support for mechanical, kinematic, and restricted kinematic alignment targets. Intellijoint HIP delivers real-time intraoperative implant measurements for primary and revision total hip arthroplasty procedures. Intellijoint KNEE provides intraoperative measurement capabilities, instrumentation alignment guidance, and bony cut positioning assistance for knee replacement implantation. The solutions target orthopaedic surgeons, surgical care teams, and healthcare administrators seeking affordable, user-friendly navigation technology that reduces complexity and cost compared to traditional systems. The company serves the US and Canadian markets and has established strategic partnerships to expand orthopaedic procedural capabilities. Products are designed for ease of use and accessibility across varying surgical facility types and surgeon experience levels.

Orthofix is a global medical device company specializing in orthopedic and spinal reconstruction solutions. The company manufactures a comprehensive portfolio of products and therapies addressing spinal conditions, limb reconstruction, and bone healing. Key product lines include spine fusion hardware and biologics (OsteoCove putty), bone growth stimulation therapies (AccelStim, CervicalStim, SpinalStim), limb reconstruction systems for congenital and acquired deformities, and the 7D FLASH surgical navigation platform—a machine-vision-enabled system offering radiation-free 3D image guidance for spine and cranial procedures. Orthofix's approach integrates mechanical, biological, and electromagnetic treatment modalities. The 7D FLASH system features streamlined registration (30 seconds vs. 30 minutes), sterile-field control, and superior surgical precision. The company serves orthopedic surgeons, spine surgeons, and orthopedic trauma specialists globally, with established clinical evidence and medical education programs supporting the complete patient pathway. Manufacturing and R&D capabilities are documented through product development initiatives and regulatory submissions. Orthofix maintains ISO and regulatory compliance appropriate to medical device classifications and operates manufacturing facilities supporting international distribution.

Fiagon GmbH is a manufacturer of electromagnetic navigation systems for ENT (otorhinolaryngology), sinus surgery, ear surgery, and cranio-maxillofacial (CMF) procedures. The company specializes in image-guided surgical navigation technology that enables precise, minimally invasive surgical planning and execution. Their product portfolio includes the Cube 4D Navigation System, which employs electromagnetic navigation to facilitate complex and routine otolaryngological procedures with high safety and efficiency. Fiagon also offers VirtuEye, a contactless photo registration system for patient positioning and registration completed in under one minute, designed for intuitive use across multiple surgical team members. The company manufactures flexible navigation instruments including PointerShells, FlexTubes, and FlexPointers that adapt to patient anatomy while enabling simultaneous functional capabilities such as suction and palpation. Their instruments support integration with standard surgical tools and burrs for comprehensive navigational guidance. Fiagon has received multiple innovation awards (Innovation of the Year 2016, Top Innovator 2015, Innovator of the Year 2014), indicating recognition within the surgical technology sector. The company serves hospitals and surgical centers globally with products designed to improve surgical accuracy and reduce operative time in complex head and neck procedures. Specific regulatory certifications and 510(k) status information were not visible in the provided content.

View Point Medical is a medical device company developing the OneMark Detection Imaging System, a surgeon-centric localization and imaging platform designed to detect and visualize visually enhanced markers placed during biopsy for precise tissue resection. The system enables intraoperative detection of marked lesions, particularly in breast cancer surgery, eliminating the need for preoperative localization device placement and reducing re-excision rates. The OneMark system represents a workflow innovation that decouples radiology and surgical scheduling while improving clinical and economic outcomes through simplified, minimally invasive localization. The company is focused initially on breast cancer indications with development underway for additional oncologic applications. Founded by experienced medical device entrepreneurs and clinical innovators, the company has assembled a leadership team with expertise in minimally invasive surgery, regulatory affairs, and medical device commercialization. The regulatory team brings over 40 years of FDA navigation experience.

EchoPixel develops a software platform that converts standard medical imaging data into interactive 4D holographic visualizations for surgical planning and intraoperative guidance. The platform creates patient-specific digital twins that physicians experience as real physical objects without requiring headgear or glasses, enabling precise visualization of complex anatomical relationships during minimally invasive procedures. The technology is particularly applied in structural heart and congenital heart interventions, providing real-time situational awareness of catheters and implantable devices relative to patient anatomy. The company's core offering addresses limitations of traditional 2D and 2.5D imaging by reducing procedure complications and expanding access to minimally invasive therapies. EchoPixel's solution is FDA 510(k) cleared and deployed in leading hospital systems. The platform serves as a turnkey surgical guidance system that integrates with existing hospital imaging workflows, designed for cardiology, interventional radiology, and cardiac surgical teams. Manufacturing and software development capabilities are based in San Jose, California.

PolarisAR Inc. develops mixed-reality surgical guidance technology for orthopedic procedures. The company's flagship product, STELLAR Knee, is a mixed-reality surgical navigation system designed for Total Knee Arthroplasty (TKA) procedures. STELLAR Knee delivers real-time, targeted surgical guidance directly onto the surgical field, enabling surgeons to simultaneously view patient anatomy and critical data. The system provides robot-like precision without the complexity or cost of conventional robotic surgery platforms. Key differentiators include seamless operating room integration with no requirement for external monitors, cameras, or towers; intuitive hand gesture and voice command control within the mixed reality environment; and compatibility with any implant system, allowing surgeons to select preferred implants while maintaining procedural flexibility. STELLAR Knee is designed to democratize access to advanced surgical technology by minimizing infrastructure costs and supporting diverse surgical workflows. The system functions as a digital surgical assistant, enhancing surgeon proficiency, workflow efficiency, and situational awareness during knee arthroplasty. PolarisAR targets orthopedic surgeons and surgical centers seeking precision guidance technology that balances advanced capability with cost-effectiveness and operational simplicity.

AA Medical, operating as AA Medical Store, is a leading distributor of new and reprocessed medical equipment specializing in the aftermarket medical device resale sector. Founded in 2010 and headquartered in Mokena, Illinois with operations in Miami, Florida, the company supplies a comprehensive range of surgical and diagnostic equipment through an extensive network of 350+ sales representatives and relationships with 2,800+ healthcare facilities. AA Medical offers one of the largest online inventories of minimally invasive surgical equipment, endoscopy systems, orthopedic instrumentation, and surgical visualization technology at competitive, cost-optimized pricing. The company specializes in pre-owned and post-lease equipment across endoscopy, orthopedics, anesthesia, urology, and gynecology, emphasizing sustainable sourcing and white-glove customer service. Key product categories include visualization systems, surgical power instruments, laparoscopy and arthroscopy equipment, orthopedic implants and tools, patient monitoring and care devices, operating room infrastructure, and laboratory equipment from trusted manufacturers including Stryker, Arthrex, Conmed, Olympus, and Karl Storz.

Carlsmed is a publicly traded medical technology company specializing in AI-enabled personalized spine surgery solutions. The company's flagship aprevo® platform integrates artificial intelligence and 3D printing technology to design custom titanium spinal implants and deliver detailed, patient-specific surgical plans. The platform includes 3D surgical planning and visualization (myaprevo®), personalized procedural protocols, and biomechanically optimized implants designed to promote fusion. FDA-cleared for lumbar and cervical spinal fusion procedures, Carlsmed has completed over 50 cases. The company targets the substantial U.S. market opportunity of approximately 445,000 annual lumbar spine fusion procedures. With strong clinical evidence foundation and ISO 13485 certification, Carlsmed is expanding internationally following its July 2025 IPO.

DIXI Medical is a specialized neurosurgical device manufacturer with over 50 years of expertise in stereotactic electroencephalography (SEEG) systems and functional neurosurgery. The company develops high-precision intracerebral electrodes, intraoperative neurophysiological monitoring systems, and stereotactic implantation accessories for epilepsy diagnosis, treatment, and brain research applications. Core product lines include MICRODEEP® SEEG electrodes (sterile, single-use with up to 18 contacts and 0.8 mm diameter for deep brain exploration and thermocoagulation), MICRODEEP® Micro-Macro electrodes (for simultaneous multi-scale neuronal recording bridging clinical and research use), and Cortical IOM electrodes for intraoperative real-time cortical monitoring and stimulation. The company also manufactures dedicated stereotactic implantation instruments and accessories. DIXI Medical serves epilepsy centers and functional neurosurgery programs in over 40 countries and supports SEEG training and research initiatives globally. Manufacturing capabilities include microtechnical precision engineering, sterilization, and quality assurance aligned with medical device standards. The company emphasizes clinical collaboration with neurosurgeons, neurologists, and researchers, with field-based clinical support teams and ongoing investment in training programs for healthcare professionals. Products are designed for compatibility with robotic stereotactic systems and are used in both surgical and research settings.

Unik Orthopedics develops personalized medical devices and cloud-based surgical planning software for total knee and hip replacement procedures. The company provides an open-platform solution combining advanced imaging analysis, customized 3D surgical planning, personalized single-use surgical instruments, and robotic-assisted technologies that work with any implant brand. Using MRI or CT imaging, the company creates precise 3D anatomical models of each patient, enabling surgeons to develop individualized surgical plans optimized for implant size, alignment, and placement. Custom instruments are manufactured in their California facility and delivered within two weeks of imaging. The technology reduces surgical steps, requires fewer instruments, and improves procedural efficiency and consistency compared to conventional instrumentation. Unik Orthopedics partners with healthcare facilities, orthopedic surgeons, and implant manufacturers to enhance patient outcomes and surgical precision. The company positions its personalized approach as reducing error margins and improving patient satisfaction in joint replacement surgery.

MediView XR, Inc. is a clinical augmented reality med-tech company specializing in first-in-class AR-powered visualization and navigation solutions for image-guided surgical and interventional procedures. The company develops mixed-reality platforms that overlay real-time 3D anatomical data, live ultrasound imaging, and procedural guidance directly into the surgeon's field of view via holographic heads-up displays. MediView's flagship products—OmnifyXR® Interventional Suite and XR90™ Holographic Surgical Navigation System—enable minimally invasive, ultrasound-guided soft tissue and bone procedures with improved ergonomics, workflow efficiency, spatial visualization depth, and real-time collaborative remote consultation and proctoring capabilities. The XR90 is FDA 510(k)-cleared and integrates seamlessly with GE HealthCare's Allia interventional imaging platform. Primary markets include interventional radiology, minimally invasive surgery, orthopedic surgery, and urological procedures. The company partners with leading academic medical centers and hospitals including The Cleveland Clinic, Mayo Clinic, NewYork Presbyterian/Weill Cornell Medicine, Memorial Sloan Kettering, and Ohio State University. MediView is Microsoft Gold partner and member of the American Medical Extended Reality Association. Recent Series A funding of $24M was led by GE HealthCare, Mayo Clinic, and Cleveland Clinic.

GuidedSMILE is a dental technology innovator specializing in digital, full-arch guided reconstruction systems for All-On-X implant surgeries. The company's flagship CHROME GuidedSMILE system enables dentists to perform preplanned surgical procedures with precision using patented anchored, stackable metal guides and fixation bases. The system delivers anchored bone reduction, site drilling guidance, abutment placement, and immediate-load prosthetics—all from a single surgical protocol. Components include Pin Guides, Fixation Bases, Osteotomy Guides, Carrier Guides, and integrated provisional prosthetics. GuidedSMILE collaborates with over 40 dental laboratories nationwide, supporting more than 10,000 full-arch cases annually. The workflow minimizes conversion time, eliminates bind-and-bend procedures, and provides complete surgical and restorative documentation transfer. Ideal for oral surgeons, implant dentists, and maxillofacial specialists seeking predictable, efficient full-arch reconstruction.

Mammotome is a global breast care company specializing in diagnostic and surgical solutions for breast cancer detection and treatment. The company manufactures vacuum-assisted breast biopsy systems, stereotactic biopsy devices, MR-guided biopsy platforms, and surgical marker navigation systems. Product portfolio includes the Mammotome PrimaTM MR System (in-room, vacuum-assisted MR breast biopsy), Mammotome RevolveTM and RevolveTM ST stereotactic biopsy systems, Mammotome DualCoreTM and Elite systems, Pintuition® surgical marker navigation system, Neoprobe® GDS gamma detection system, and comprehensive biopsy site markers (HydroMARKTM Plus, standard markers). The company serves 60 countries with 550+ associates across 9 global locations. Mammotome holds FDA clearances for its MR biopsy systems and markers, and Health Canada approval for the Pintuition® System. As a Danaher-owned company, Mammotome integrates advanced imaging compatibility and procedural efficiency into products designed for radiologists, surgeons, and pathologists in hospital and outpatient diagnostic centers.

Cadwell Industries is a family-owned American manufacturer specializing in neurodiagnostic, neuromonitoring, and sleep diagnostic medical devices. Founded in 1979 and headquartered in Kennewick, Washington, the company employs approximately 260–281 people and maintains a strong commitment to in-house research and development. Cadwell's product portfolio includes the Sierra EMG/NCS/EP/Ultrasound systems for electromyography, nerve conduction studies, and evoked potentials; Arc EEG systems for electroencephalography and epilepsy monitoring; Cascade IONM equipment for intraoperative neurophysiological monitoring; and ApneaTrak HSAT and PSG systems for sleep diagnostics. The company also manufactures a comprehensive range of electrodes, consumables, supplies, and accessories for neurology applications. Cadwell serves hospitals, clinics, and home-care settings with global distribution, supported by dedicated customer service, online training resources, and educational workshops.

Surgical Theater, Inc. develops eXperiential Reality (XR) platforms that transform 2D medical imaging (MRI, CT, DTI) into interactive 3D surgical models using AI-driven reconstruction technology. The company serves neurosurgery, spine surgery, and otolaryngology specialties with three primary solutions: PlanXR™ for preoperative surgical planning and rehearsal; Brain STORM™ for epilepsy care management; and SyncAR® (Spine and Cranial variants) for real-time intraoperative augmented reality visualization. Additional products include XR Studio™ for multidisciplinary case reviews and education within XR headsets, and ConveyXR™ for patient engagement and informed consent. The platform enables surgeons to visualize patient-specific anatomy, identify critical structures (nerves, blood vessels), and simulate complex procedures before entering the operating room. Deployed at leading academic medical centers including Mayo Clinic, Stanford, Mount Sinai, Houston Methodist, UCSF, and NYU Langone, among others. The technology derives from advanced flight simulation methodologies applied to surgical visualization. Regulatory status and specific FDA clearances not explicitly stated on fetched content, though clinical research studies referenced. Serves both academic and community hospital markets internationally.

Citieffe is an Italian orthopedic and trauma surgery medical device manufacturer headquartered in Calderara di Reno, Bologna. The company specializes in trauma and extremity solutions, limb reconstruction, and surgical navigation systems for orthopedic trauma surgeons. Their primary product portfolio centers on intramedullary nailing systems for fracture fixation, notably the EBA One Single Lag Screw nailing system, which has been expanded in the U.S. market with the introduction of the EBA One Medium nail. The company positions itself as delivering essential, versatile solutions combining creativity, technological innovation, and high-quality standards for traumatology and orthopedic reconstruction. Citieffe maintains an active presence at major orthopedic conferences including AAOS (American Academy of Orthopaedic Surgeons), SECOT (Spanish Society of Orthopedic Surgery), and the Trauma Meeting in Italy, indicating significant engagement with international orthopedic and trauma markets. The company distributes through international partners and maintains a dedicated U.S. market presence. Citieffe s.r.l. is registered with Italian business authorities (Codice Fiscale 00574250379, Partita Iva 00516271202) with significant capital base (€4.7 million). The company emphasizes surgeon-centric design principles: essential instrumentation, simplified and reproducible operative procedures, and versatile utilization across patient populations. Information and technical materials on the site are directed toward healthcare professionals.

Soteria Medical B.V. is a specialized medical device manufacturer focused on MRI-guided in-bore prostate biopsy solutions. The company has developed a proprietary Remote Controlled Manipulator (RCM)—a fully MRI-compatible robotic device for precision prostate interventions. The RCM enables real-time, near real-time targeting of suspicious prostate lesions within the MRI bore, significantly improving diagnostic accuracy for prostate cancer detection and reducing the need for multiple unnecessary biopsy cores. The RCM system addresses key clinical challenges: it delivers high diagnostic accuracy (reported 70% prostate cancer detection rates), reduces procedure duration (typically under 30 minutes), minimizes patient discomfort by eliminating general anesthesia, and improves specimen quality for pathological analysis. The device features intuitive planning software and remote needle-guide positioning, enabling radiologists to perform precise, guided biopsies with minimal patient motion and reduced in-bore time. Soteria Medical's technology has been validated by leading radiologists across multiple institutions in Europe (Spain, Italy, Netherlands, France, Norway), with testimonials emphasizing clinical safety, diagnostic efficiency, and positive patient experience compared to transrectal ultrasound (TRUS) guidance. The company's offering is positioned for hospital radiology departments and diagnostic imaging centers specializing in urologic oncology and prostate cancer diagnosis. Recent market recognition includes CMS introduction of dedicated CPT codes (55713, 55714) for in-bore MR-guided prostate biopsy, reflecting clinical differentiation and reimbursement support in the US market. Soteria Medical is an active participant in major medical imaging conferences (ECR).

Ceevra is a medical software company that develops FDA-cleared machine learning and computer vision algorithms to generate detailed, interactive 3D digital models from CT and MRI imaging studies. The platform automatically processes imaging data without requiring manual input from hospital personnel and delivers 3D surgical visualization accessible on mobile devices, tablets, laptops, and integrated surgical robotic displays. Ceevra's 3D models are clinically validated to improve surgical planning and patient outcomes across multiple surgical specialties including thoracic, urologic, gynecologic, and general/hepatopancreaticobiliary (HPB) surgery. The solution supports open, laparoscopic, and robotic-assisted surgical approaches. Clinical evidence published in JAMA Network Open demonstrates significant improvements in surgical outcomes, including enhanced cancer control, functional preservation, and reduced adjuvant therapy rates in robotic urologic procedures. Ceevra serves major U.S. healthcare systems including UCLA Health, Mayo Clinic affiliates, Memorial Sloan Kettering, Baptist Health South Florida, and Tulane University School of Medicine. The company operates on a subscription model with implementation designed for rapid deployment across hospital networks.

ImmersiveTouch develops advanced surgical planning and visualization software leveraging virtual reality and augmented reality technology for trauma and reconstructive surgery. The company provides patient-specific imaging analysis and immersive 3D visualization platforms (ImmersiveView, ImmersiveAR) that enable surgeons to plan complex procedures with enhanced spatial understanding and accuracy. Their solutions are deployed across 100+ sites in 6+ surgical specialties including craniofacial and maxillofacial surgery, plastic and reconstructive surgery, orthopedics, neurosurgery, thoracic surgery, and general surgery. Over 3,000 surgical cases have been completed using ImmersiveTouch technology. Customers include major academic medical centers and trauma hospitals such as Mayo Clinic, Cleveland Clinic, MD Anderson, Shriners Hospitals for Children, Walter Reed, and University of Illinois Health. The platform integrates with patient imaging data to create manipulable 3D models viewable in VR headsets, reducing surgical time and improving preoperative planning accuracy. The company operates from Chicago, Illinois, and serves both hospital systems and private surgical practices.

Augmedics Ltd. manufactures xvision, an FDA-approved augmented reality surgical navigation system for spine surgery. The technology uses AR headset visualization to overlay 3D anatomical data directly into the surgeon's field of view during procedures, eliminating the need to look away from the patient to reference external monitors. xvision is indicated for open, minimally invasive, and percutaneous spine procedures from C3 through the pelvis, including single and multi-level degenerative, trauma, revision, and complex deformity cases. Clinical data demonstrates 97–100% accuracy in pedicle screw placement and has been deployed in over 12,000 patient treatments with 66,000+ screws navigated. The platform integrates preoperative or intraoperative registration, operates on an open architecture, and features an intuitive 3D interface with minimal learning curve. Augmedics positions the technology as reducing radiation exposure, improving surgical efficiency, shortening operative times, and enhancing patient outcomes while maintaining surgeon workflow and control. The company emphasizes broad procedural applicability, economic scalability, and reproducible outcomes supported by peer-reviewed clinical evidence.

Navigate Surgical Technologies develops the Inliant System, a dynamic surgical navigation platform for freehand dental implant procedures. The system uses real-time motion tracking of the clinician's handpiece and patient position, overlaying precise drill angulation and trajectory on CBCT scans displayed in real-time during surgery. The platform comprises three core components: an attachment-free dental handpiece (requiring no pre-surgical calibration), a patient tracker set affixed to a chairside-fabricated stent for maintaining registration with the CBCT scan, and an optimized cart with full-length arm and adjustable monitor designed for any operatory configuration. The system enables same-day implant planning and surgery, eliminates or reduces intraoperative radiographs, and allows adaptive surgical planning in real-time. Primary clinical applications include single and multiple implant placement in aesthetically challenging zones, areas with questionable bone volume, limited vertical space, diverging roots, or tight interdental spacing. The Inliant System has received FDA 510(k) clearance. Navigate targets oral and maxillofacial surgeons, periodontists, and general dentists performing implant procedures.

MindTrace is a Pittsburgh-based AI/ML software platform (Carnegie Mellon University spinoff, founded 2020) designed to support neurosurgical planning and intraoperative decision-making. The platform integrates multiple data sources to enable clinicians to predict cognitive outcomes before, during, and after brain surgery. MindTrace provides structured neurocognitive assessment workflows—measuring language, memory, attention, and other critical functions—allowing surgical teams to iterate on resection strategies while evaluating trade-offs between lesion removal and preservation of healthy brain tissue. The system integrates into clinical, operating room, and epilepsy monitoring workflows, supporting inpatient, perioperative, intraoperative, and telehealth settings. Used across U.S. medical centers under IRB oversight, MindTrace bridges clinical neurocognitive assessment with translational research data collection, enabling reproducible multi-site studies without custom infrastructure. The platform serves neurosurgeons, hospitals, researchers, and patients seeking evidence-based preoperative surgical planning and quantitative projections of postoperative function and quality of life.

Globus Medical, Inc. is a musculoskeletal medical device company specializing in spine surgery, orthopedic implants, and enabling surgical technologies. The company develops procedurally integrated portfolios for minimally invasive and open spine procedures, including TLIF (Transforaminal Lumbar Interbody Fusion), XLIF (Lateral Lumbar Interbody Fusion), and expandable interbody spacers. Key technology platforms include Excelsius Technology (an ecosystem of advanced OR technologies), Advanced Materials Science featuring PEEK and titanium implants, and proprietary magnetically adjustable systems for limb reconstruction (Precice). The company manufactures cervical disc replacements (Simplify Cervical Disc), power instruments (Verzera and DuraPro), and surgical navigation systems designed to improve safety and clinical outcomes. Globus Medical serves spine surgeons, orthopedic surgeons, and hospital systems globally through a comprehensive portfolio addressing sagittal alignment, fusion, fixation, and patient anatomy protection. The company emphasizes procedural integration, clinical education, and surgeon training through its Medical Education & Research Center (MERC), offering multimodal learning pathways and continuing surgical education. Manufacturing capabilities include advanced materials processing and enabling technology integration. The organization operates with regulatory compliance across major markets and demonstrates commitment to improving quality of life for patients with musculoskeletal disorders through innovation and surgeon partnership.

Cision Vision is a medical technology company specializing in shortwave infrared (SWIR) imaging systems for pathology and surgical applications. Founded in 2020 as an MIT spinoff, the company's flagship InVision device provides label-free, real-time imaging that enhances lymph node identification and tissue grossing in laboratory and intraoperative settings. The technology leverages SWIR wavelengths (1000–2000 nm) to penetrate biological tissues deeply and provide natural contrast based on water and lipid content, eliminating the need for contrast agents or radiation. InVision has been recognized as one of Time Magazine's Best Inventions of 2023 and is deployed across multiple U.S. hospitals. The company's surgical application focuses on AI-powered critical structure identification during intraoperative guidance. Cision Vision has received significant government funding, including a prestigious ARPA-H award of up to $22.3 million as part of the Biden Cancer Moonshot initiative. The company collaborates with leading institutions including Johns Hopkins Medicine and Stanford Medicine, and operates the Visionary Program to support early-access initiatives for pathology innovators. Clinical validation includes a multicenter study published in the Journal of Clinical Pathology.

Illuminant Surgical develops real-time surgical navigation systems using artificial intelligence, computer vision, and dynamic projection mapping to enhance image-guided procedures. The company's flagship product, Skylight™, is a non-invasive anatomical projection system designed for spine surgery and interventional access procedures. Skylight projects imaging directly onto the patient's anatomy, eliminating the cognitive burden of traditional navigation systems that require surgeons to mentally translate 2D scans into 3D spatial awareness while constantly shifting attention between screens and the surgical field. The system employs SkinMatch™ patient registration technology to streamline workflow integration into any procedure room with minimal training (one day) and setup time (minutes rather than 30+ minutes). Illuminant Surgical addresses a critical gap in surgical technology by making advanced navigation accessible beyond major medical centers—scaling the solution to ambulatory surgical centers, private specialty clinics, and pain management facilities. The company's technology reduces operational friction, decreases OR costs, and expands treatment capacity. As of the website content, Skylight has not received FDA clearance and is not available for commercial use. The company is led by co-founders listed in Forbes 30 Under 30 Healthcare and is advised by prominent clinical and engineering leaders from USC Spine Center, Stanford Biodesign, and Stanford Medical Mixed Reality Lab, as well as business advisors including the founder of Masimo and former Stryker executive.

Radlink, Inc. is a medical device software company specializing in intraoperative imaging navigation and surgical guidance systems for orthopedic surgery, with primary focus on hip arthroplasty (total hip replacement). The company develops AI-powered software platforms that integrate with standard fluoroscopy (C-arm and mobile X-ray) systems to provide real-time, patient-specific surgical guidance without requiring specialized hardware or invasive tracking. Core products include Radlink One Touch (redesigned surgeon's checklist interface), Radlink Hip (anterior and posterior approach THA software), Radlink3D (3D intraoperative assessment of acetabular cup and femur positioning with spinopelvic mobility analysis), Panoramic Fluoro (panoramic fluoroscopic imaging), and OrthoPlan 2.0 (preoperative planning). The platform operates as an open system compatible with any implant brand and any C-arm or mobile X-ray device on the market. Software enhancements include spinopelvic assessment for functional component positioning and leg length discrepancy prediction. Radlink also offers DR Pro (digital radiology software) and PACS/EMR/Citrix integration capabilities. The company markets to surgeons, hospitals, and health systems seeking to improve OR efficiency, reduce costs, and enhance clinical accuracy. Headquarters: El Segundo, California. The technology is clinically validated with peer-reviewed publications in orthopedic journals and is actively promoted through industry conferences including AAHKS (American Association of Hip and Knee Surgeons).

Caira Surgical is a New York-based medical technology company founded in 2019, specializing in advanced software, scanning, and precision radar technologies for orthopedic joint replacement surgery. The company develops radar-based surgical tracking systems delivering sub-millimeter accuracy and navigation platforms designed to enhance surgical precision, reduce setup time, and improve patient outcomes. Caira's proprietary technology is protected by multiple U.S. patents (11,432,882, 11,351,007, 11,510,739, with additional patents pending). The company's first product is a navigation system for knee replacement utilizing fast anatomic landmark registration, with planned expansion to hip, shoulder, and spine procedures. Caira emphasizes reliability, intuitive adoption, efficiency (5x reduction in technology setup time), and affordability (10x cost improvement over conventional systems), making advanced navigated and robotic surgery accessible to diverse surgical settings.

ZETA Surgical Inc. designs and manufactures AI-powered frameless neuronavigation systems for cranial surgery and neuromodulation procedures. The company's core platform, REALTRACK™, delivers real-time image-guided navigation with submillimeter accuracy and live continuous surgical guidance tracking patient movement at 20 times per second. The system eliminates the need for cranial pin fixation and general anesthesia, enabling bedside procedures in operating rooms, emergency settings, and ambulatory surgical centers. Primary clinical applications include external ventricular drain (ventriculostomy) placement, brain biopsy, transcranial magnetic stimulation (TMS) targeting, and tumor resection such as cavernoma removal. Clinical data demonstrates 100% single-pass catheter placement success for ventriculostomy (versus 81% freehand), 100% ideal placement (versus 32% freehand), zero adverse events and revision surgeries. The TMS Navigation System achieved FDA 510(k) clearance in October 2025. ZETA's technology integrates AI-based image analysis, ultra-fast system setup, and real-time guided intervention. The company is backed by leading neurosurgeons and research institutions including Harvard Medical School, Brigham and Women's Hospital, and Imperial College London. ZETA serves hospital operating rooms, neurosurgical centers, and interventional procedure suites primarily in the United States.

NaviNetics Inc. is a medical device company founded by researchers, engineers, and neurosurgeons from the Neural Engineering Laboratories at Mayo Clinic in Rochester, Minnesota. The company specializes in stereotactic neurosurgery systems for precise target localization and patient head fixation during minimally invasive procedures. Their flagship product is the NaviNetics Reusable Stereotactic System, a frame-based neurosurgical targeting platform designed for deep brain stimulation (DBS), lesioning, biopsies, targeted injections, aspirations, and minimally invasive tumor treatments. The system combines the accuracy and workflow efficiency of traditional frame-based systems with a compact, ergonomic design. Key features include skull anchor fixation (eliminating the need for a base frame), intuitive targeting adjustments, excellent burr hole access, and procedural sterile field integrity. The system is compatible with standard CT and MR imaging localizers, enabling planning workflows consistent with conventional DBS frame methodology. Optional adapters support integration with third-party microdrive systems (AO and FHC). The product is designed to improve patient experience, accelerate DBS workflow, and maintain the accuracy verification standards expected in neurosurgical applications. NaviNetics targets hospitals and surgical centers performing stereotactic neurosurgery, with particular focus on DBS programs and functional neurosurgery.

RG Medical USA manufactures endoscopic instrumentation and robotic surgical navigation systems for minimally invasive urology and ENT procedures. Core product portfolio includes the Robotic Navigation Genius—a multifunctional robotic platform compatible with endoscopes, instruments, microscopes, and navigation systems for precision-guided surgical applications. The company also produces endoscopic instruments including the Morcescope Universal (available in 19/22, 22/24, and 24/26 Fr sizes) and the Duo Mono-Bipolar system for bipolar saline resection procedures (22/24 and 24/26 Fr). Products are designed for transurethral resection and other minimally invasive endoscopic procedures. RG Medical maintains multilingual customer support (English, Spanish, German) and operates from a US location with international distribution capabilities. The company positions itself in the premium surgical instrumentation and robotic navigation segment, serving hospitals and surgical centers performing advanced urological and endoscopic procedures.

Novarad Corp is a medical software and digital imaging solutions company headquartered in Provo, Utah, with over 30 years of innovation in enterprise medical imaging. The company specializes in PACS (Picture Archiving and Communication Systems), enterprise imaging, and augmented reality surgical navigation. Novarad's product portfolio serves hospitals ranging from 26 to 500+ bed facilities, critical access hospitals, rural hospitals, imaging centers, and clinics. Core offerings include NovaPACS with Enterprise Imaging (customizable PACS platform with HL7 integration capabilities), VisAR (FDA-approved fully immersive 3D augmented reality surgical navigation system for spine and cranial neurosurgery), MobileRad 360 (mobile EMR ecosystem), Nova RIS (radiology information system), CryptoChart (medical image sharing), NovaCardio (cardiology solutions), and MammoIQ (mammography software). The company supports cloud, on-premises, edge, and hybrid deployment models. Novarad maintains strategic partnerships with major healthcare IT vendors including eClinicalWorks, NextGen, Medent, and others. The company is known for USA-based 24/7 customer support and implementation services. VisAR has received FDA clearance for precision spine surgery and regulatory approval in Indonesia for stereotactic spine surgery. The company demonstrates expertise in enterprise imaging interoperability, workflow optimization, and specialized imaging across radiology, cardiology, and mammography.

Ruthless Spine manufactures the RJB™, an intraoperative surgical angle measurement tool designed for lumbosacral pedicle screw placement procedures. The RJB system measures axial and sagittal angles of surgical instruments relative to gravity in real-time, providing surgeons with precise angle tracking during spinal surgery. The device connects via Bluetooth to standard tablets (Android OS 10+ or iOS 14+) and displays real-time visualization of instrument trajectory in two planes. The RJB offers a cost-effective alternative to traditional surgical navigation systems, eliminating the need for expensive, bulky imaging equipment while maintaining ease of use with minimal training requirements and simple 30-second setup. Each single-use RJB module provides up to 8 hours of continuous operational use. The device is FDA-cleared (De Novo clearance DEN230012) as a measurement tool and does not provide surgical guidance, navigation, or assistance against patient anatomy. Ruthless Spine positions the RJB as an elegant, efficient solution addressing the barriers—cost, complexity, and learning curve—associated with conventional surgical navigation for spine procedures.

Gyder Surgical US Inc manufactures the GYDER® Hip System, a patented pin-less surgical navigation platform designed for anterior hip replacement procedures. The system enables image-free, pin-less navigation without requiring CT or X-ray imaging, reducing radiation exposure and procedural complexity. The GYDER® Hip System features a non-invasive approach with no fixative fixation points, simple setup with rapid calibration, and seamless integration into existing OR workflows. The platform operates as an open system compatible with surgeon-preferred implant systems, supporting both traditional OR and ambulatory surgery center (ASC) environments. Designed for portability with minimal medical waste generation, the system facilitates precise surgical placement while reducing operative time and patient burden. Currently available for distribution in the United States and Australia, the GYDER® Hip System targets orthopedic surgeons and surgical facilities performing hip arthroplasty procedures. The company markets directly to physicians and through distributor channels.

Brain Navi is a Taiwan-based neurosurgical medical device company specializing in advanced surgical navigation and visualization systems for intracranial procedures. The company manufactures two primary product lines: NaoTrac, an autonomous neurosurgical navigation robot that guides surgeons to target locations following pre-planned surgical pathways, and KrystoLens, a single-use 2D/3D neuro-endoscope with a wide surgical working channel designed for minimally invasive intracranial surgery. NaoTrac achieved FDA clearance in June 2025 and has been deployed at leading neurosurgical centers including Medizinische Universität Lausitz in Germany. The company's mission is to improve surgical accuracy, streamline neurosurgical procedures, and reduce surgeon learning curves. Products are designed for neurosurgeons performing brain and spinal procedures requiring high precision and visualization. Brain Navi serves international markets and participates in major medical conferences and surgical events to demonstrate clinical applications and train surgical teams.