Functional Diagnostics in New Jersey

Vision RT Limited is the market leader in Surface Guided Radiation Therapy (SGRT), a 3D surface imaging technology that tracks patient position and motion throughout the entire radiotherapy workflow to improve safety, effectiveness, and efficiency of cancer treatment. The company offers an integrated suite of solutions spanning simulation, planning, treatment, and dose verification. SimRT is a single-camera contactless system for 4D and breath-hold CT monitoring during the simulation phase, eliminating the need for physical surrogates and demonstrating 3x greater accuracy than traditional methods. MapRT is a dual-camera solution that maps safe beam angles during treatment planning to improve plan quality and deliverability while the patient is in the CT room. AlignRT is the flagship real-time motion management system for the treatment room, available in standard and InBore configurations, with specialized modules for patient ID verification, respiratory gating, stereotactic radiosurgery, and postural coaching. DoseRT leverages Cherenkov-enabled imaging to visualize radiation delivery in real-time and detect dose errors, reducing secondary cancer risk. Vision RT systems are deployed in over 3,000 oncology clinics globally, including 24 of the top 25 U.S. cancer hospitals. The technology supports all cancer types including breast, prostate, lung, liver, head and neck, brain, and sarcoma, with specialized applications for proton therapy, deep inspiration breath hold, stereotactic radiosurgery, and pediatric patients. AlignRT reduces treatment times by an average of 22% per fraction. The company has published extensively in peer-reviewed journals and holds regulatory clearances for clinical use. Vision RT operates with approximately 25 years of SGRT expertise and maintains UK-based operations.

Advanced Tactile Imaging, Inc. develops pioneering biomechanical mapping and digital twin technologies for women's pelvic healthcare. The company designs and manufactures novel diagnostic devices that quantify tactile properties of vaginal and pelvic floor tissues to support clinical evaluation and diagnosis of pelvic floor dysfunction, cervical conditions, and preterm birth risk. Primary product portfolio includes the Vaginal Tactile Ultrasound Imager (TIUSv), which combines tactile imaging with ultrasound fusion for functional assessment; the Vaginal Tactile Imager (VTI), a standalone tactile diagnostic device; and the Cervix Monitor (CM) for cervical assessment. The technology platform employs tactile ultrasound imaging methodology to provide objective, quantifiable biomechanical integrity scoring of pelvic floor tissues. The company has published peer-reviewed research in journals including Military Medicine, Open Journal of Obstetrics and Gynecology, Journal of Pelviperineology, and SCIRP, demonstrating clinical applications in spontaneous preterm birth prediction and comparative analysis across military and civilian populations. In 2025, Advanced Tactile Imaging received a USA patent for its method of characterization of the female pelvic floor with biomechanical integrity scoring. The company exhibits at major international medical trade shows, including MEDICA (Dusseldorf, 2025), indicating active market engagement. Clinical evidence and patent portfolio support regulatory development pathway for diagnostic medical devices in obstetrics and gynecology.

Becton, Dickinson and Company (BD) is a global medical technology leader founded in 1897 with approximately $20.2 billion in FY2024 revenue. BD supplies a comprehensive portfolio spanning diagnostic and laboratory solutions, surgical products and instruments, medication management systems, and infection prevention technologies. The company pioneered disposable syringes (Plastipak™) and blood collection systems (BD Vacutainer®), and operates automated blood culture and diagnostic platforms. Through strategic acquisitions including CareFusion and C.R. Bard, BD expanded capabilities in medication management, surgical interventions, and hospital systems. Current offerings address ambulatory surgery centers, diagnostic accuracy and specimen collection workflows, patient safety and infection control, advanced clinical analytics through BD HealthSight Advisor, medication management optimization, and surgical efficiency. BD Incada™ Connected Care Platform represents the company's digital health integration strategy. With global operations across alternate sites, diagnostic labs, research areas, hospital units, pharmacy, and surgical suites, BD serves healthcare systems seeking integrated solutions to improve patient outcomes and operational efficiency.

Access Bio, Inc. is a global in vitro diagnostics (IVD) manufacturer headquartered in Monroe Township, New Jersey. The company specializes in rapid diagnostic tests and molecular diagnostics for infectious disease detection, with a primary focus on malaria, HIV, HPV, and COVID-19. Access Bio's product portfolio includes rapid point-of-care tests, COVID-19 antigen and molecular (PCR) assays, serology tests, and automated laboratory analyzers. The company has received multiple FDA Emergency Use Authorizations (EUA) for COVID-19 detection kits, including a 10-minute antigen test and molecular tests with results in 83 minutes or less. Access Bio serves international public health agencies, healthcare systems, and research organizations globally. The company holds FDA regulatory approvals and maintains manufacturing and distribution capabilities through established supply chain partnerships. Recent regulatory milestones include FDA-granted shelf-life extensions for the CareStart COVID-19 Antigen Home Test (extended to 21 months at 1–30°C storage). Access Bio is positioned as a leader in infectious disease diagnostics with operations across the US, South Korea, and other international markets. The company actively pursues partnerships with healthcare providers, educational institutions, and global health organizations to expand access to diagnostic solutions.

QuidelOrtho Corporation is a global in vitro diagnostics company providing diagnostic solutions across clinical laboratory, transfusion medicine, molecular testing, and point-of-care applications. The company offers over 550 assays across multiple testing modalities including real-time PCR, rapid lateral-flow immunoassays, automated immunohematology systems, and benchtop analyzers. Key product platforms include LYRA™ real-time PCR assays (open platform molecular testing), QUICKVUE™ rapid lateral-flow tests for infectious diseases and point-of-care diagnostics, TRIAGE™ System for point-of-care immunoassays, VITROS™ benchtop clinical chemistry systems, SOFIA™ 2 Analyzer for rapid diagnostics, ORTHO VISION™ Swift automated blood bank analyzers, ORTHO™ Workstation semi-automated immunohematology analyzer, and ORTHO OPTIX™ Reader for transfusion lab testing. The company serves clinical laboratories, hospitals, point-of-care settings, and home-testing markets in 140+ countries. QuidelOrtho recently completed acquisition of Lex Diagnostics, expanding its diagnostic portfolio. The company manufactures diagnostic instruments, reagents, and assays for infectious disease detection (virology, molecular, immunoassay), blood banking, clinical chemistry, and specialty testing. Products are regulated as in vitro diagnostic devices under FDA and international standards.

Nano-Ditech Corporation is a manufacturer of rapid immunodiagnostic products for point-of-care and in vitro diagnostic testing. The company specializes in the development and manufacturing of lateral flow immunoassay-based diagnostic tests for infectious diseases and cardiac biomarkers. Their product portfolio includes rapid antigen tests for COVID-19, influenza A+B, RSV, and dual influenza/COVID-19 testing, as well as fluorescence-based tests for procalcitonin (PCT) and NT-proBNP cardiac markers. These products are designed for rapid results suitable for clinical settings, urgent care, and home testing environments. Nano-Ditech's manufacturing capabilities support both single-analyte and multiplexed diagnostic platforms. The company maintains product catalogs and instructions for use (IFU) documentation available through their website, indicating compliance with regulatory documentation requirements. Their focus on rapid immunodiagnostic innovation positions them as a supplier to hospitals, clinical laboratories, diagnostic distributors, and institutional buyers requiring point-of-care testing solutions for infectious disease screening and cardiac risk stratification.

Immunostics Inc. is a point-of-care diagnostics manufacturer specializing in rapid diagnostic tests across women's health, infectious disease, and toxicology. The company develops and distributes in vitro diagnostic (IVD) products for clinical and home-use settings. Primary product lines include hemoglobin/hematology analysis (hemochroma+), fecal occult blood testing (hema-screen SPECIFIC GOLD), and COVID-19 antigen testing (Swab-N-Go Home Test). Swab-N-Go carries FDA Emergency Use Authorization. Immunostics maintains a global distribution network with headquarters in Eatontown, NJ and subsidiary operations through Boditech Med Inc. (parent/Korean manufacturer), European operations via MEDIMARK® EUROPE SARL, and offices in Indonesia and China. The company focuses on affordable, accessible point-of-care diagnostics with emphasis on ease of use and rapid turnaround for healthcare professionals and consumers. Products are designed to support disease diagnosis across clinical laboratory and point-of-care environments.

MedaCure Inc. is a manufacturer and distributor of durable medical equipment (DME) and supplies headquartered in Kenilworth, New Jersey. The company designs and manufactures a comprehensive range of products for senior healthcare, long-term care, homecare, and behavioral health settings. MedaCure's product portfolio includes long-term care beds, patient lifts and slings, wheelchairs, bariatric equipment, bathroom safety products, mattresses, patient room furniture, and respiratory and diagnostic devices including portable oxygen concentrators and bladder scanners. The company operates distribution centers across the USA to ensure rapid delivery and provides professional consultation services to healthcare facilities for product selection. MedaCure emphasizes quality, competitive pricing, and rigorous quality control standards supported by ongoing research and staff training. The company also offers warranty servicing and supports both institutional buyers and homecare providers with equipment tailored to enhance patient safety and comfort.

Infervision is a global medical artificial intelligence company founded in 2015, specializing in deep learning technologies for medical imaging and clinical diagnostics. Headquartered in Beijing with a US office in Lyndhurst, New Jersey, Infervision develops AI-powered platforms designed for radiologists and clinicians to enhance diagnostic accuracy and clinical workflows. The company's InferRead™ suite processes over 33,000 exams daily and provides comprehensive imaging analysis across multiple organ systems including lungs, cardiovascular, breast, and bone. InferOperate™ offers surgical planning and intraoperative navigation, while InferScholar™ and InferMatrix™ platforms support medical research and innovation. Infervision's solutions assist in detecting conditions such as lung cancer, stroke, pneumonia, tuberculosis, and fractures from various imaging scans. The company holds regulatory approvals from the US FDA, China NMPA, EU CE, UK UKCA, and Japan PMDA, with products deployed across 1,000+ medical institutions in 30+ countries.

Princeton BioMeditech Corporation (PBM) is a world leader in rapid, point-of-care diagnostic products. The company manufactures and distributes an extensive portfolio of over 70 different one-step rapid diagnostic tests utilizing patented immunoassay technologies. PBM serves both consumer in-home and professional on-site/point-of-care markets with FDA-cleared and ISO 13485:2016 certified products. Product lines include rapid antigen detection tests for COVID-19/Flu, cardiac markers, infectious disease diagnostics, fertility testing, drugs of abuse screening, tumor markers, and food/environmental pathogen detection. The company offers OEM services, point-of-care analyzer systems, research and development capabilities, and comprehensive product support. Based in Princeton, New Jersey, PBM maintains USA manufacturing operations and serves healthcare providers, clinical laboratories, and consumers globally.

LifeSign LLC is a medical diagnostic company specializing in high-quality rapid point-of-care (POC) testing solutions for the healthcare industry. The company manufactures and distributes a comprehensive portfolio of diagnostic test kits and reagents across multiple clinical specialties, including infectious disease, women's health, cardiac care, urology, gastrointestinal health, drugs of abuse screening, hygiene, and industrial applications. Key product lines include the Status™ rapid test platform, covering COVID-19/Flu A&B multiplex testing, influenza B, mononucleosis, and strep A detection. LifeSign serves hospitals, clinics, urgent care centers, and other healthcare facilities requiring rapid, reliable diagnostic results at the point of care. The company emphasizes early detection and rapid diagnosis to improve clinical outcomes. LifeSign maintains manufacturing and quality systems appropriate for medical device distribution, with products distributed through a national sales and support network. The organization is positioned as a B2B supplier of diagnostic consumables and testing solutions for various medical markets.