Catheterization Lab Equipment in California
41 vendors serving California
Find catheterization lab equipment vendors in California. MedIndexer lists vendors headquartered in California alongside nationwide vendors that serve California. Compare profiles, review service areas, and contact vendors directly — no middleman, no fees for buyers.
Top catheterization lab equipment in California
SureAx Medical Corp.
SureAx Medical Corp. is a San Diego-based manufacturer of specialized vascular access devices for lymphatic interventions and imaging procedures. The company designs and manufactures in-house innovative needles and access tools for lymphatic system procedures. Primary product lines include the SureAx-HOOK™ needle, designed for lymph node anchoring during lymphography and interstitial lymphatic embolization, and the SureAx-CURVE™ needle, engineered for accessing the cisterna chyli and thoracic duct with improved navigation and catheterization capabilities. The curved distal end and bevel-rotation design of the CURVE™ needle facilitate precise targeting and reduce procedure time. SureAx Medical serves interventional radiologists and physicians specializing in lymphatic interventions across US hospitals and international facilities. The company emphasizes close collaboration with physicians to develop tools that improve procedural efficiency and patient outcomes. Beyond product manufacturing, SureAx offers comprehensive 2-day hands-on training courses covering lymphatic imaging theory, anatomical and physiological principles, and practical applications including intranodal lymphangiography, thoracic duct access, duct embolization, and lymphoplasty techniques. The company has expanded from its initial needle focus into broader surgical applications and continues to develop new products addressing unmet clinical needs in lymphatic interventional procedures.
CathWorks
CathWorks is a medical device company specializing in AI-driven interventional cardiology software and systems. The company's flagship product is the FFRangio® System, a non-invasive physiologic assessment platform used in cardiac catheterization laboratories. The FFRangio System combines artificial intelligence and advanced computational science to derive fractional flow reserve (FFR) measurements directly from routine angiographic images, eliminating the need for invasive pressure wires and drug stimulation (adenosine). The system provides real-time physiologic data at multiple points along the coronary tree, enabling interventional cardiologists to assess lesion severity and ischemia non-invasively during coronary angiography procedures. Key features include simulated pullback curves for functional CAD pattern differentiation, Lesion Impact analysis for residual ischemia assessment post-intervention, and integrated sizing tools for non-invasive lesion measurements. The CathWorks FFRangio System is deployed across major U.S. health systems including Northwell Health, Hackensack Meridian Health, Lehigh Valley Health Network, and AdventHealth, with documented adoption milestones such as Lenox Hill Hospital reaching 1,000 cases. The technology is positioned for interventional cardiologists and interventional radiologists performing coronary angiography and percutaneous coronary intervention (PCI) procedures. The company emphasizes workflow efficiency, procedural planning optimization, and improved clinical decision-making through comprehensive hemodynamic and morphologic data integration.
ExThera Medical Corporation
ExThera Medical Corporation develops and commercializes the Seraph® 100 Microbind® Affinity Blood Filter, a single-use, extracorporeal blood filtration device designed to reduce pathogen levels in the bloodstream for patients with life-threatening bloodstream infections, sepsis, and related critical care conditions. The Seraph 100 employs proprietary microbead adsorption media with chemically-bonded modified heparin to selectively bind and remove pathogens—including bacteria, viruses, and endotoxins—from circulating blood while leaving the blood itself intact in the filter. The technology has been studied for COVID-19 treatment and is now advancing into clinical trials for broader infectious disease applications and oncology-related conditions through pipeline programs including ONCObind®. The company is advancing Phase I clinical trials (OSCAR I) for bloodstream infection management and exploring applications in pancreatic cancer treatment. ExThera's extracorporeal blood purification approach addresses a critical unmet need in intensive care settings where pathogenic load reduction can improve outcomes in sepsis, severe infections, and related hemodynamic compromise. The company maintains regulatory development pathways and publishes peer-reviewed clinical and preclinical data. Manufacturing and quality systems support single-use, sterile device production for hospital and critical care deployment.
FMD Co., Ltd. (株式会社エフエムディ)
FMD Co., Ltd. is a Japanese medical device manufacturer specializing in minimally invasive catheter-based therapeutic equipment, particularly guidewires for peripheral vascular interventions. The company conducts research, development, and manufacturing of guidewires essential for low-invasiveness catheter therapy. FMD operates multiple facilities including headquarters in Tokyo, a Saitama manufacturing plant, an Okinawa facility, and an R&D center. The company manufactures both OEM products for major medical device partners (including an exclusive U.S. distribution agreement with Medtronic for peripheral guidewires in 0.014" and 0.018" diameters) and proprietary branded products. Product lines include guidewire systems such as the F-14 and F-18 series, as well as electrode catheters including EPSkinny and EPLumy (lumen-bearing electrode catheter). FMD maintains quality assurance systems and serves interventional cardiology and peripheral vascular intervention markets globally, with particular focus on transradial access procedures. The company was founded in 2015 according to copyright information and maintains active partnerships with major multinational medical device companies for distribution and co-development.
HeartFlow, Inc.
HeartFlow develops AI-driven software for coronary artery disease (CAD) diagnosis and management, transforming Coronary Computed Tomography Angiography (CCTA) imaging into personalized 3D cardiac models. The company's flagship platform, Heartflow One, combines CCTA imaging with proprietary FFR_CT (fractional flow reserve) analysis to assess coronary blood flow, identify plaque characteristics, and guide treatment decisions without invasive catheterization. The Heartflow One platform comprises three core analytical modules: Roadmap™ Analysis (CAD detection and anatomy assessment), FFR_CT Analysis (functional assessment of coronary stenosis to determine revascularization benefit), and Plaque Analysis (quantitative plaque characterization for risk stratification). Additionally, HeartFlow offers PCI Navigator for pre-procedural planning in percutaneous coronary intervention. The company serves over 1,800 healthcare institutions across the United States and internationally, with coverage reaching 99.5% of the US population. HeartFlow's technology is supported by over 600 peer-reviewed publications and has been endorsed by clinical statements from the American College of Cardiology and American Heart Association for personalized CAD management. The platform addresses significant diagnostic gaps in conventional methods (stress testing, PET, SPECT), which exhibit 20–30% false negatives and 55% false positives. HeartFlow provides institutional support beyond software, including clinical, operational, technical, and financial resources for CCTA program development and scaling.
Allwin Medical Devices
Allwin Medical Devices is a leading manufacturer of specialized medical devices headquartered in Anaheim, California, with manufacturing facilities in India. The company specializes in four primary product categories: Women's Health (IVF/assisted reproduction), Urology, Gastroenterology, and Interventional Radiology. Founded by executives with over 30 years of combined experience in the medical device industry, Allwin is committed to delivering high-quality devices at affordable prices to healthcare providers globally. The company currently serves customers across multiple continents and actively participates in major medical conferences including ASRM (American Society for Reproductive Medicine), ESHRE (European Society of Human Reproduction and Embryology), and REDLARA. Recent certifications include ISO 13485 (2025), demonstrating compliance with international quality management standards for medical device manufacturers. Allwin's product pipeline includes specialty micropipettes and denuding pipettes designed for oocyte and embryo manipulation during IVF procedures, with emphasis on minimizing oocyte degeneration. The company serves fertility clinics, urology departments, gastroenterology facilities, and interventional radiology centers, positioning itself as an accessible alternative to premium-priced competitors while maintaining clinical quality standards.
DynaFlex Technologies Inc.
DynaFlex Technologies Inc. is a medical device manufacturer specializing in catheter design, polymer solutions, and automated manufacturing equipment for interventional cardiology and neurovascular applications. The company provides comprehensive solutions spanning catheter development (braided, coiled, deflectable, steerable, and micro-catheters), advanced polymer extrusion with medical-grade materials including multi-layer extrusion and low-durometer polymers, and semi-automated to AI-driven equipment for catheter production and rapid prototyping. DynaFlex serves neurovascular, cardiovascular, structural heart, vascular therapy, and stimulation therapy markets. The company manufactures PFAS-free polymer alternatives, including their proprietary EverGlide+ series, which is E-beam sterilizable and designed for delamination-free performance in critical clinical applications. Headquarters operations are located in Irvine, California, with additional polymer solutions facility in Yorba Linda, California, rapid prototyping laboratory in Fremont, California, and production facility in Taiwan. The company is ISO 13485:2016 certified and supports both rapid prototyping and full-scale production with seamless technology integration for OEM partners and medical device manufacturers.
JAM-Labs Corp
JAM-Labs Corp is a medical technology company specializing in AI-powered surgical environment solutions and operating room integration systems. The company designs and manufactures hardware, software, FPGA, embedded systems, and mechanical solutions for perioperative environments. Their product portfolio includes advanced OR recording and visualization devices, integration systems, and intelligent digital platforms that enhance surgical workflows, patient safety, and OR efficiency. JAM-Labs serves hospitals and surgical centers with solutions designed for surgeons, nursing staff, trainees, and healthcare administrators. The company emphasizes real-time data insights, automation through AI algorithms, error prevention systems, and seamless integration with existing perioperative workflows. Their offerings address OR performance optimization, staff collaboration, surgical documentation, and procedure recording with high-resolution 4K visualization. JAM-Labs targets institutional healthcare markets and has demonstrated presence in catheterization labs and surgical suite environments, with customer testimonials from hospital networks and specialized surgical centers.
Innova Vascular, Inc.
Innova Vascular, Inc. is a medical device company headquartered in Irvine, California, specializing in minimally invasive solutions for treating vascular thromboembolism and peripheral vascular disease. The company develops and commercializes thrombectomy devices targeting acute pulmonary embolism and peripheral arterial occlusions. Core product line: the Laguna Thrombectomy System, which comprises the Laguna Clot Retriever™ System and Malibu Aspiration Catheter™ System. Both devices received FDA 510(k) clearance in June 2023 for use in the peripheral vasculature. Early commercial deployment has been reported at UCLA Medical Center (Los Angeles) and Providence St. Joseph (Orange, California) as of February 2024. The company is actively enrolling clinical sites for the TRUST (Treating Pulmonary Embolism With Laguna Thrombectomy System) study to evaluate the system's safety and efficacy in pulmonary embolism treatment. Founded by Dr. Sanjay Shrivastava, who brings over 20 years of medical device development and commercialization experience from senior roles at Johnson & Johnson, Medtronic, BTG plc, and Covidien/ev3. The leadership team includes board members with expertise in orthopedics, business development, and venture capital, and commercial leadership includes VP of Sales Paul Mullen and Commercial Advisor John Zehren. Regulatory: FDA 510(k) cleared. Founder holds 30+ issued US patents and numerous international patents in medical device design and materials. Markets served: interventional cardiology, peripheral vascular intervention, and acute vascular disease management at teaching hospitals and regional medical centers.
Penumbra, Inc.
Penumbra, Inc. is a global medical device company headquartered in Alameda, California, with manufacturing and service facilities in Livermore, CA and Salt Lake City, UT. The company specializes in innovative catheter-based systems for minimally invasive treatment of acute ischemic stroke, pulmonary embolism (PE), and venous thromboembolism (VTE). Primary product lines include the Penumbra System (mechanical thrombectomy platform) and the Lightning Flash series (aspiration catheter technology for PE and clot management). The Penumbra System RED comprises reperfusion catheters, separators, aspiration tubing, and aspiration pump components designed for interventional neuro-endovascular procedures treating large vessel occlusion within the intracranial circulation (internal carotid, middle cerebral M1/M2, basilar, and vertebral arteries) within 8 hours of symptom onset. Lightning Flash 3.0 represents the latest generation CAVT (Controlled Aspiration and Vacuum Thrombectomy) technology for acute PE and venous thrombus management. Products are indicated for patients ineligible for or refractory to intravenous thrombolytic therapy. The company maintains global distribution through offices in Europe, Latin America, and Canada. Penumbra devices are single-use, sterile systems requiring specialized physician training in interventional endovascular techniques. Manufacturing capabilities include precision catheter coating, sterile packaging, and quality systems supporting regulatory requirements for FDA-cleared and CE-marked devices. The company serves interventional radiology, neurovascular, and vascular surgery specialties in hospital and interventional center settings.
Curatia Medical
Curatia Medical is a FDA, CE MDR, and CFDA-approved interventional disposables manufacturer headquartered in Sunnyvale, CA, with manufacturing operations in Suzhou, China. Founded in 2015, the company specializes in designing, manufacturing, and distributing single-use catheters and vascular access devices for cardiac, peripheral, neuro, and pulmonary interventional procedures. The product portfolio includes angiographic catheters (URSA®), guiding catheters (XCESS®), balloon dilatation catheters (Vela™, Bilia, Navajo®), introducer sheath sets (EXTesia), distal access catheters (HW-Flex), aspiration catheters (Laredo Plus), hemostasis valve kits (AutoSeal™), and long sheath sets (Crosera). EXTesia introducer sheath received FDA approval in April 2022; Crosera long sheath set obtained NMPA approval in August 2024. The company maintains ISO 13485:2016 certification, meets FDA 21 CFR Part 820, EU MDR (2017/745), NMPA YY/T 0287-2017, and Korea GMP standards. Curatia operates a global sales network spanning more than 30 countries across North America, Europe, South America, and Asia. The company also provides OEM manufacturing services for customers. Multiple unannounced FDA and TÜV SÜD on-site audits have resulted in zero findings, demonstrating compliance with quality and regulatory requirements.
South53
South53 is a medical device startup developing innovative solutions for vascular access procedures. The company is focused on improving safety, speed, and effectiveness of interventional radiology and interventional cardiology applications through proprietary guide wire control technology and enhanced needle visualization systems. Currently in stealth-mode development with recent seed funding, South53 is advancing toward first-in-human studies and regulatory submissions. The company's product platform emphasizes first-attempt success rates, intuitive control mechanisms, and integrated needle-guide wire designs optimized for clinical efficiency in vascular access procedures.
INDIAN WELLS MEDICAL, INC.
Indian Wells Medical, Inc. is a Southern California-based medical device manufacturer specializing in cardiology and electrophysiology procedure solutions. The company develops minimally invasive interventional devices designed to improve clinical outcomes in cardiac catheterization and electrophysiological interventions. Their primary product line includes the FlexPoint® family of steerable transseptal needles (STSN) and piercing stylets (PS), which are used in left heart access procedures and complex arrhythmia ablation interventions. These devices are engineered to provide enhanced steerability and precision in transseptal puncture applications, critical for procedures such as left atrial appendage (LAA) closure, atrial fibrillation ablation, and mitral valve interventions. The company serves interventional cardiologists, electrophysiologists, and cardiac centers performing structural heart and arrhythmia procedures. Indian Wells Medical focuses on innovation in catheterization laboratory equipment and procedural tools that enable safer, more precise cardiac interventions.
STELLARTECH RESEARCH CORP.
Stellartech Research Corporation is an ISO 13485:2016-registered contract manufacturer and product development partner specializing in sophisticated medical devices utilizing radiofrequency, ultrasound, and other energy-delivery sources. The company designs and manufactures complex medical systems that typically combine disposable patient-contact devices with microprocessor-controlled instruments featuring advanced electronics for sensor feedback and controlled therapeutic energy delivery. Core competencies include catheter-based systems (including balloon electrode catheters), surgical probes, diagnostic instruments, and minimally invasive therapy devices. Stellartech operates a 68,000 sq. ft. facility capable of manufacturing Class II and Class III devices under FDA QSR compliance and ISO 13485:2016 quality management systems. Beyond contract manufacturing, the company provides full-spectrum product development services—from concept and proof-of-principle through clinical evaluation, regulatory approval, and market introduction. Stellartech partners with device companies of all sizes, medical entrepreneurs, physicians, and investment groups, offering incubation services for new medical device enterprises using its manufacturing infrastructure and regulatory expertise. The company brings integrated capabilities in RF and ultrasound energy systems, complex electronics design, catheter technology, and regulatory pathway management, positioning it as a strategic partner for medical device innovators seeking to navigate the product development lifecycle.
Endologix LLC
Endologix LLC is a US-based medical device company specializing in endovascular aortic repair (EVAR) solutions for patients with vascular disease, particularly abdominal aortic aneurysm (AAA). The company develops and markets minimally invasive interventional devices and systems designed to address unmet clinical needs in vascular interventions. Endologix's primary product portfolio includes EVAR systems and the DETOUR System, a novel device for peripheral vascular interventions. The company has received recognition for medical device engineering innovation and emphasizes clinical evidence-based development. Endologix is also pioneering virtual reality (VR) procedural training programs for physicians, positioning itself as an innovator in both device technology and physician education. The company is headquartered in Irvine, California, and focuses on serving interventional cardiologists and vascular surgeons through specialized vascular intervention solutions.
Embolx Inc.
Embolx Inc. is a medical device company specializing in advanced microcatheters for arterial embolization procedures. As a subsidiary of Edwards Lifesciences, the company develops innovative solutions for interventional oncology and related specialties, including treatments for cancerous tumors, benign prostatic hyperplasia (BPH), and uterine fibroids. The flagship product, Sniper® Balloon Occlusion Microcatheter, enables precise delivery of embolic agents with controlled blood flow pressure management. The latest generation, Sniper G3 (launched July 2025), offers improved efficiency and ease of use for healthcare providers. Embolx products are available in US and European markets and serve interventional radiologists and specialists performing minimally invasive embolization procedures.
Inquis Medical, Inc.
Inquis Medical, Inc. is a clinical-stage medical device company specializing in interventional solutions for venous thromboembolic (VTE) diseases, including pulmonary embolism (PE) and deep vein thrombosis (DVT). The company develops the AVENTUS Precision Thrombectomy System, a catheter-based device engineered for precise clot removal while minimizing blood loss during endovascular interventions. The AVENTUS system incorporates proprietary TrueClot™ Sensing technology for real-time tissue differentiation, directional aspiration for targeted clot retrieval, and integrated autologous blood return to optimize procedural efficiency and patient outcomes. The device received FDA 510(k) clearance for PE treatment in June 2025 and has completed successful clinical trials. Founded in 2019, Inquis Medical is based in Menlo Park, California, with a mission to deliver "care without compromise" in interventional cardiology and peripheral vascular medicine.
Filmecc Co., Ltd.
Filmecc Co., Ltd. is a precision manufacturer of custom-made flexible ultra-fine wire ropes and tubing engineered for minimally invasive medical devices, particularly catheterization and interventional cardiology applications. The company specializes in high-torsional-rigidity shaft components that enable one-to-one torque transmission, critical for guidewires, catheter shafts, and endoscopic instruments. Core manufacturing capabilities include diamond wire drawing (achieving tolerances <2 μm and minimum diameters of 0.01 mm), wire forming and rope construction, advanced torque technologies, and proprietary coating systems including PTFE liners and braided tubing. Materials processed include stainless steel (SUS304/316), Nitinol, and Tungsten. The company maintains in-house production across compounding, extrusion, dipping, and specialized polymer coating operations. Products include torque hypotubes, braid-reinforced catheter shafts, PTFE-lined tubing, thin-film surface conductor technology, and magnetic sensor products (nT Meter). Filmecc serves interventional cardiologists, endoscopy manufacturers, and medical device OEMs requiring precision microtubular components with exacting mechanical specifications. The company provides custom engineering and prototyping capabilities for device manufacturers developing minimally invasive therapeutic and diagnostic instruments.
Upstream peripheral Technologies ltd.
Upstream Peripheral Technologies Ltd. is an Israeli medical device manufacturer specializing in peripheral vascular intervention catheters. The company produces the GoBack® Crossing Catheter, a minimally invasive device designed for crossing chronic total occlusions (CTOs) in peripheral arteries, particularly in below-the-knee (BTK) and in-stent restenosis cases. The GoBack catheter features a unique needle-based design with selectable protrusion lengths and axial/lateral positioning capabilities, enabling both intraluminal crossing and guidewire support in heavily calcified lesions. Available in two configurations—4Fr with 0.018" guidewire and 2.9Fr with 0.014" guidewire—the device offers excellent pushability, torqueability, and directional control. Clinical applications include in-stent restenosis crossing, occluded stent management, retrograde crossing, and SFA (superficial femoral artery) interventions. The GoBack catheter holds CE Mark approval and FDA 510(k) clearance. Note: The GoBack catheter product line was acquired by Bentley in 2022; current inquiries should be directed to Bentley Global for product support and sales.
TSK LABORATORY, JAPAN
TSK Laboratory International is a Japan-based manufacturer specializing in custom needle solutions and medical devices for pharmaceutical and medical device companies worldwide. The company develops and manufactures specialty needles with proprietary designs and materials, supported by multiple patents. Primary markets served include aesthetic medicine, interventional radiology, ophthalmology, and dental applications. Core product lines include low dead space needles (minimizing product loss in syringes), STERiGLIDE cannula systems (optimized for reduced tissue trauma and bruising), and custom needle projects tailored to pharmaceutical partners' specifications. The company emphasizes innovation in needle design and materials to improve clinical outcomes, patient safety, and injection comfort. TSK Laboratory maintains CE mark certification and serves as a preferred partner for leading global pharmaceutical and medical device manufacturers. While the site references custom solutions for pharma companies, the primary business model centers on needle and cannula manufacturing rather than finished pharmaceutical products.
Imperative Care Inc.
Imperative Care is a medical technology company specializing in innovative solutions for stroke and vascular disease interventions. Founded in 2016, the company operates four business units addressing the complete patient journey from acute intervention to post-acute recovery. The Imperative Care Stroke unit develops interventional devices including the Zoom Stroke System for rapid mechanical clot removal across a wide range of vessels in ischemic stroke patients. The Vascular unit offers the Symphony® Thrombectomy System for venous thromboembolism treatment and the Prodigy® Thrombectomy System for acute limb ischemia management. Telos Health is developing a robotic platform to enhance precision, standardization, and accessibility of vascular procedures. Kandu Health provides digital health support for stroke survivors. The company emphasizes rapid clinical innovation and partnerships with healthcare providers to improve patient outcomes across the stroke and vascular disease spectrum.
Boston Scientific Corporation
Boston Scientific Corporation is a global medical device manufacturer serving multiple clinical specialties including cardiology, urology, gastroenterology, interventional radiology, electrophysiology, neurology, pain management, vascular surgery, and structural heart disease. The company manufactures and distributes a broad portfolio of minimally invasive medical devices, including cardiac rhythm management systems, interventional cardiology devices, electrophysiology catheters and mapping systems, spinal cord stimulation systems for pain management, urological devices, endoscopy and visualization systems, defibrillators, and interventional oncology equipment. Boston Scientific operates a healthcare professional portal providing online training through EDUCARE, e-commerce ordering, reimbursement resources, and comprehensive customer support with specialty-specific representative contact networks. The organization serves hospitals, ambulatory surgery centers, and healthcare professionals across the United States through direct sales and support teams organized by medical specialty. Products undergo rigorous regulatory compliance (FDA 510(k), international certifications) and the company emphasizes quality assurance and product safety as core organizational values. Customer care is available via a dedicated U.S. customer service line, with extended business hours Monday–Friday.
NeuroVasc Technologies, Inc.
NeuroVasc Technologies, Inc. is a California-based medical device company founded in 2015, specializing in the development and commercialization of catheter-based technologies for neurovascular disease treatment, with particular focus on acute ischemic stroke management. The company leverages over 100 years of combined expertise in neurovascular device design and maintains regulatory clearance to serve patients in more than 35 countries. NeuroVasc's product portfolio includes novel mechanical thrombectomy systems, aspiration catheters, and micro/intermediate delivery catheters designed for endovascular intervention. The EnviSR is the company's flagship stent retriever for mechanical thrombectomy, supported by clinical evidence from IDE trials in the United States and pivotal randomized controlled trials in China. The company is actively advancing its pipeline through clinical development programs, including the ENVI RCT—a U.S. IDE clinical trial for ischemic stroke treatment. NeuroVasc manufactures devices meeting regulatory standards across multiple international markets, with products designed to address the growing clinical need for effective acute stroke intervention. The company's development strategy emphasizes innovation in catheter design, ease of use, and clinical efficacy for treating neurovascular emergencies.
Gravity Medical Technology
Gravity Medical Technology develops next-generation stroke intervention devices designed to expand global access to mechanical thrombectomy treatment. The company manufactures the Supernova Revascularization Device, a stent-based thrombus retrieval system with patented spiral fusiform cell design and dynamic strut architecture, and the Neutron Reperfusion Catheter, engineered for smooth trackability and fluoroscopic visibility in acute ischemic stroke management. Both products are integrated within the Neutron Stroke Solution portfolio for comprehensive mechanical thrombectomy intervention. The Supernova device received regulatory approval in India (August 2025) and is supported by clinical evidence from the GRASSROOT trial led by AIIMS, with results published in the Journal of Neurointerventional Surgery. Gravity addresses the clinical gap that 97% of the global population lacks access to stroke treatment, focusing on sustainable, reliable deployment of advanced revascularization technology in underserved regions. The company maintains manufacturing and clinical operations across the United States, Thailand, and India, with active case studies and deployments documented in India, Pakistan, and Southeast Asia. Products feature laser-cut, self-expanding stent platforms with retrievable design and kink-resistant catheters optimized for varied healthcare infrastructure settings.
Renata Medical
Renata Medical is a MedTech startup headquartered in Newport Beach, California, specializing in minimally invasive medical devices for pediatric cardiology. Founded in 2019, the company develops innovative solutions to address unmet clinical needs in congenital heart disease and pediatric vascular stenosis. The flagship product, Minima Growth Stent System, is the first and only FDA-approved stent designed specifically for infants weighing over 1.5 kg. This breakthrough device features a gradual re-expansion mechanism that accommodates a child's growth from infancy through adulthood, eliminating the need for multiple interventional procedures. Minima represents a transcatheter alternative to traditional open-heart surgery, reducing operative burden while improving long-term outcomes in the neonatal and pediatric population. Renata Medical's leadership comprises experienced professionals with deep expertise in transcatheter devices and pediatric cardiology, ensuring clinically relevant product development and market deployment strategies.
EchoPixel, Inc.
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.
Radiology Oncology Systems, Inc
Radiology Oncology Systems (ROS) is a US-based refurbished medical equipment distributor specializing in radiation therapy and diagnostic imaging systems for hospitals, radiation oncology centers, and clinics worldwide. With 25+ years of experience, ROS sources, inspects, reconditions, and installs pre-owned linear accelerators (Varian, Elekta), CT simulators and scanners (GE Optima, Siemens), PET/CT systems (GE Discovery), MRI machines, and X-ray equipment to OEM specifications. The company offers end-to-end project management including equipment selection, procurement, shipment, delivery, installation, staff training, and ongoing service. ROS maintains a global network of engineers and has successfully completed over 1,600 projects across 67 countries, partnering with more than 700 facilities. All ROS-certified equipment undergoes rigorous inspection and is guaranteed to meet original manufacturer specifications. Beyond sales, ROS provides equipment relocation, repair, maintenance, appraisals, parts sourcing through its Radparts division, and equipment removal/disposal services. The company targets cost-conscious healthcare systems seeking reliable, clinically-capable equipment without new-device capital expenditure. Corporate office located in San Diego, California; parts and warehousing operations based in Michigan.
AngioSafe
AngioSafe is a medical device company specializing in endovascular revascularization solutions for coronary and peripheral artery disease. The company develops the Santreva-ATK platform, a wire-free intraplaque crossing and vessel preparation system designed for treating chronic total occlusions (CTOs) and severely stenotic lesions. Santreva-ATK combines three integrated mechanisms—intraplaque traversal, axial plaque cutting, lateral plaque compression, and channel formation—in a single, manually controlled, large-profile catheter system. The device is engineered to minimize complications including embolism, flow-limiting dissection, and major perforation in complex coronary and peripheral interventions. AngioSafe's technology addresses a significant clinical gap in endovascular intervention by simplifying CTO crossing procedures and reducing procedural complexity. The Santreva-ATK platform underwent clinical validation in the RESTOR-1 pivotal trial, which demonstrated successful revascularization outcomes with zero device-related major adverse events and high antegrade crossing success rates. The company positions its solution as catheterization laboratory equipment for interventional cardiologists and vascular specialists managing complex coronary artery disease. AngioSafe serves hospital cath labs and interventional centers focused on advanced coronary and peripheral revascularization procedures.
Nipro Vascular Innovations Americas, Inc.
Nipro Vascular Innovations Americas, Inc. is a medical device company specializing in intravascular imaging platforms for coronary and peripheral interventional cardiology. The company manufactures and distributes advanced catheter-based diagnostic systems that provide high-resolution structural imaging and plaque composition analysis to guide percutaneous coronary intervention (PCI) and peripheral vascular interventions. Primary product lines include Clarispro® HD-IVUS (intravascular ultrasound for vessel structure visualization), Dualpro® IVUS+ NIRS (dual-modality system combining intravascular ultrasound with near-infrared spectroscopy to identify lipid-core plaques and assess plaque vulnerability), and Makoto® Intravascular Imaging (integrated platform combining structural and compositional imaging for real-time treatment guidance). These technologies are designed to reduce major adverse cardiac events (MACE) and improve clinical outcomes in interventional procedures. The company serves interventional cardiologists, interventional radiologists, and vascular specialists in hospital catheterization laboratories and outpatient intervention centers. Nipro Vascular Innovations Americas represents the consolidation of formerly independent companies Infraredx and Avantec Vascular under the Nipro brand, leveraging combined expertise in optical coherence tomography (OCT), intravascular ultrasound (IVUS), and near-infrared spectroscopy (NIRS) technologies. Products are intended for use in coronary and peripheral vascular diagnostics and are subject to FDA regulation as Class II/Class III medical devices.
M4D LLC
M4D LLC is an ISO 13485:2016-certified and FDA-registered medical device manufacturer specializing in the design, development, prototyping, testing, validation, and full-scale manufacturing of endovascular technologies. The company operates three dedicated cleanrooms across 12,000 sq. ft of GMP-compliant facility space, including ISO Class 8 (100K) cleanroom areas. M4D serves as a strategic partner for medical device innovators, providing comprehensive contract manufacturing services from initial concept and design through regulatory compliance and commercialization. With over 70 years of combined industry experience, M4D specializes in complex catheter manufacturing capabilities including catheter winding, marker band swaging, segment fusing, and hydrophilic coating application. The company is committed to quality-driven innovation and maintains rigorous supply chain management and regulatory compliance protocols to support the development of therapies that improve patient outcomes.
Okami Medical Inc.
Okami Medical Inc. is a California-based medical device manufacturer specializing in vascular occlusion systems for interventional radiology and endovascular procedures. The company's flagship product is the LOBO® HD BRAID® Vascular Occluder, a proprietary high-density braided occlusion device engineered for rapid and complete vascular occlusion in peripheral arteries. The LOBO system achieves occlusion in an average of 90 seconds using a single device across a wide range of clinical cases, positioning it as an alternative to traditional coil-based and plug-based embolization approaches. The company also offers complementary delivery systems including the SENDERO Microcatheter and SENDERO MAX Delivery Catheter, both designed for peripheral vasculature applications supporting diagnostic and therapeutic agent infusion. Indicated uses include arterial occlusion and flow reduction in peripheral vasculature for applications such as tumor embolization, renal artery occlusion, bronchial artery embolization, and pulmonary arteriovenous malformation (PAVM) treatment. The LOBO system is FDA-cleared (Rx-only device) and supported by published case studies demonstrating clinical efficacy. Okami operates from Aliso Viejo, California, and provides technical support and clinical education to interventional radiologists and vascular specialists. The company emphasizes rapid deployment and simplified procedural workflows as key differentiators.
Shape Memory Medical Inc
Shape Memory Medical Inc develops and manufactures embolization devices utilizing proprietary smart polymer technology. The company specializes in the IMPEDE Embolization Plug family of devices designed for peripheral vascular and interventional procedures. Their regenerative smart polymer platform is engineered to conform dynamically to patient anatomy while promoting the body's natural immune response and cellular healing. The devices are radiolucent, enabling superior visibility during and after procedures, and feature high porosity to facilitate rapid clot formation and durable occlusion. The material is bioabsorbable without chronic inflammatory response. Shape Memory Medical's smart polymer technology represents an advancement beyond traditional embolization materials, offering improved procedural outcomes through anatomic conformability, enhanced visualization, and biocompatible healing properties. The company supports clinical evidence through publications, registered clinical trials (including the Shape RCT for abdominal aortic aneurysm applications), and case studies demonstrating clinical efficacy. Products are indicated for peripheral embolization and expanding cross-specialty applications. The company is positioned as a developer of innovative interventional device solutions for vascular and endovascular procedures.
Vesalio, Inc
Vesalio, Inc is a medical device company specializing in mechanical thrombectomy systems for acute arterial occlusions across neurovascular, coronary, and peripheral vascular territories. The company manufactures a comprehensive platform of patented thrombectomy devices leveraging proprietary Drop Zone™ technology designed to maximize clot retention and first-pass recanalization success. Primary product lines include: NeVa (neurovascular stroke thrombectomy), NeVa NET (next-generation neurovascular system with integrated micro-filter), NeVa VS (post-aneurysmal subarachnoid hemorrhage cerebral vasospasm treatment), enVast (coronary thrombectomy for large thrombus burden), pVasc (peripheral arterial occlusion thrombectomy), and NeVaSC (aspiration catheter). The company holds multiple regulatory clearances including FDA 510(k) clearances for several product lines and CE marks for international markets. Vesalio addresses a significant clinical need across three major disease areas: ischemic stroke (approximately 15 million cases annually, 80% clot-related), acute myocardial infarction (8.5 million cases annually, 30% clot-related), and acute limb ischemia (2.5 million cases annually, 80% clot-related). The platform is supported by robust clinical evidence, with published cases and peer-reviewed data demonstrating high recanalization rates and clinical efficacy across multiple vascular territories.
InterVene Inc
InterVene, Inc. is a medical device company specializing in interventional treatment of venous pathology, specifically venous in-stent restenosis (ISR) and thrombotic venous obstructions. The company has developed the first fully integrated mechanical thrombectomy system designed to address clinical challenges associated with venous ISR and residual thrombotic venous obstructions and occlusions where current therapeutic options (balloon angioplasty, stent relining) have proven ineffective. ISR is a frequent complication following venous stenting procedures, with published literature indicating substantial patient populations develop ISR with organized, non-acute thrombus composition. The company also addresses postthrombotic syndrome (PTS), a long-term sequela of deep vein thrombosis affecting 20-50% of DVT patients, which presents with persistent leg swelling, pain, skin changes, and in severe cases, venous leg ulcers. Current conservative treatment options for PTS are limited and include anticoagulation therapy, compression stockings, leg elevation, and lifestyle modifications, with no definitive cure available. InterVene's mechanical thrombectomy platform represents an innovation in addressing these persistent unmet clinical needs in venous intervention.
Shockwave Medical, Inc.
Shockwave Medical is a medical device company specializing in intravascular lithotripsy (IVL) systems for the treatment of cardiovascular calcification. The company manufactures the Shockwave IVL platform, which uses sonic pressure waves to disrupt arterial calcium deposits, enabling improved vessel preparation and reducing complications during interventional cardiology and peripheral vascular procedures. Shockwave offers two primary product lines: Coronary IVL systems for treatment of calcified coronary lesions and Peripheral IVL systems for peripheral arterial disease. The devices are designed to simplify calcium modification with a low complication profile and intuitive user interface. The company serves interventional cardiologists, vascular surgeons, interventional radiologists, and hospitals globally. Shockwave Medical maintains FDA-cleared devices and pursues reimbursement coverage, with ongoing efforts to expand coverage for both coronary and peripheral indications. The company operates from its corporate headquarters in Santa Clara, California, with international offices supporting European markets. Educational initiatives and clinical evidence generation are central to market development strategy.
VASOINNOVATIONS INC.
VASOINNOVATIONS INC. manufactures the VASOBand, an FDA-cleared hemostasis device designed for radial artery compression management in interventional cardiology procedures. The VASOBand is the only patent hemostasis device capable of concomitant ipsilateral ulnar artery compression, distinguishing it from competing compression devices. Clinical evidence supports its efficacy in reducing radial artery occlusion (from 10.2% to 1.6%), hematoma formation (from 6.3% to 0.8%), and rebound bleeding (from 8.7% to 1.6%) while achieving patent hemostasis in 97% of cases. The device enables faster patient recovery with reduced post-operative monitoring requirements and eliminates the need for additional staff training. The wider band design prioritizes patient comfort and integrates seamlessly into existing workflows for interventional cardiology teams. The company is based in South Pasadena, California, and operates a direct-to-customer ordering model through their website.
EverX USA LLC
EverX USA LLC is a pre-owned medical imaging equipment and parts supplier established in 1992 with operations in Sydney, Australia and the United States. The company specializes in sourcing, refurbishing, and distributing high-quality used diagnostic imaging systems and components to small medical facilities, independent clinics, and service organizations seeking cost-effective alternatives to new equipment. Core product offerings include CT scanners, MRI systems, X-ray systems, ultrasound equipment, C-arm fluoroscopy systems, catheterization lab (cath lab) equipment, mammography systems, PET/CT systems, and nuclear medicine/gamma camera equipment. EverX maintains extensive inventory of OEM parts and components from major manufacturers including GE Healthcare, Siemens, Philips, Toshiba, Hitachi, Hologic, and Canon. Specialized offerings include MRI coils and replacement parts for all major imaging modalities. The company also acquires used equipment directly from facilities upgrading their imaging suites, providing trade-in and equipment buyback services. EverX serves the healthcare market by enabling smaller facilities to access advanced diagnostic imaging technology at reduced capital expenditure, addressing both diagnostic imaging needs and equipment lifecycle management. No specific regulatory certifications (FDA, ISO, CE) are mentioned on the site.
Alpha Medical Instruments, Inc.
Alpha Medical Instruments, Inc. is a manufacturer of cardiac balloon catheters and related catheterization equipment, founded in 2005 and based in Mission Viejo, California. The company specializes in the design, manufacturing, and assembly of balloon flotation catheters intended for venous catheterization of the right side of the heart, enabling measurements of venous, right heart, and pulmonary artery pressures, as well as cardiac output determination. Product lines include wedge pressure catheters, angiographic catheters, thermodilution catheters, multipolar pacing catheters (bipolar and hexapolar configurations), and DPX introducer sets. The company's quality system is certified to meet US FDA Quality System Regulation (QSR) requirements and complies with ISO 13485:2016 standards for medical device manufacturing. Alpha Medical serves healthcare institutions requiring specialized cardiac monitoring and hemodynamic assessment equipment.
Toro Neurovascular, Inc.
Toro Neurovascular is a medical device company specializing in advanced catheter technology for acute ischemic stroke intervention. The company develops and commercializes innovative aspiration thrombectomy devices designed to improve first-pass efficacy and reduce procedure times in large vessel occlusion (LVO) treatment. Their flagship product line includes the Toro™ 88 guide catheter and MicroFlex™ technology platform, which features reinforced catheters with enhanced flexibility for navigation through complex cerebrovascular anatomy. The MicroFlex™ design enables intuitive handling regardless of patient anatomy, allowing physicians to achieve higher intracranial positioning of large-bore (8F) catheters in the petrous segment and beyond. Clinical data demonstrates that elevated guide catheter positioning in aspiration thrombectomy correlates with higher first-pass effect rates and shorter procedure times. Toro Neurovascular targets interventional neuroradiology and neurosurgery practices focused on acute stroke care. The company is led by experienced medical device entrepreneurs with background in interventional catheter development, regulatory affairs, quality assurance, and global commercial operations. The organization addresses a significant clinical market: ischemic stroke affects 795,000+ patients annually in the United States and represents the leading cause of long-term disability worldwide, with an annual healthcare cost exceeding $104 billion.
Q'Apel Medical Inc.
Q'Apel Medical Inc. is a neurovascular medical device manufacturer based in Fremont, California, specializing in innovative neurological catheters and access systems for stroke intervention and cerebral aneurysm treatment. Founded in 2015, the company designs advanced catheter technologies that enable therapeutic thrombectomy and neurovascular procedures with enhanced precision and patient outcomes. Q'Apel's product portfolio includes the Walrus Balloon Guide Catheter system, recognized as a leading variable-stiffness device for mechanical thrombectomy in the U.S. market; the Wahoo Control™ and Armadillo SelectFlex™ Neurovascular Access Systems, engineered for superior navigation and variable stiffness performance; and the recently FDA-cleared Zebra Neurovascular Access System. The company's devices are deployed across over 130 U.S. hospital systems and have treated more than 20,000 patients since 2019. Q'Apel is actively pursuing international expansion and continued innovation in endovascular access technology.
Verge Medical Inc.
Verge Medical (formerly Ostial Corporation) is a privately held medical technology company specializing in vascular intervention devices for coronary and peripheral markets. The company's flagship product is the FLASH™ (Flared Lesion Angioplasty System with Hemodynamic optimization) Ostial Angioplasty System, a novel dual-balloon device designed for aorto-ostial stenting in both coronary and peripheral indications. The FLASH system employs patented dual-balloon technology: a non-compliant distal balloon for system anchoring and a compliant, low-pressure proximal balloon that conforms the stent to the ostial wall, achieving TRUE 360° flared apposition. Clinical data demonstrates 97% complete stent apposition rates and restenosis below 9% at 6 months. Over 25,000 FLASH systems have been sold across more than 300 US hospitals. In addition to the FLASH system, Verge Medical recently acquired the RoVo™ System featuring Temporary Occlusion Embolectomy (TOE) technology for peripheral embolic protection and the Wavella™ technology from Crossfire Medical to expand its interventional portfolio. The company operates in both inpatient and office-based settings. Products are indicated for use by trained interventional cardiologists and vascular specialists. The company maintains regulatory clearance for its devices and emphasizes physician training and support. Verge Medical is backed by institutional investors including Delos Capital and AMED Ventures.