Company Product Description Indication Status
Bardy Diagnostics Inc., of Seattle Carnation Ambulatory Monitor patch P-wave centric ambulatory cardiac patch monitor Detects arrhythmia Received CE mark certification for the 14-Day version
Beyond Air Inc., of Garden City, N.Y. Lungfit Nitric oxide (NO) generator and delivery system Treatment of patients with respiratory conditions Received Health Canada approval to study usage in COVID-19 patients
Genscript Biotech Europe BV, of Leiden, Netherlands Cpass SARS-CoV-2 Surrogate Virus Neutralization Test Kit Contact tracing, reservoir or intermediate animal tracking, assessment of herd immunity, the longevity of protective immunity and efficacy of different vaccine candidates Obtained CE marking for its SARS-CoV-2 diagnostic products to be sold as an in vitro diagnostic
Merit Medical Systems Inc., of South Jordan, Utah Wrapsody endovascular stent graft system Flexible self-expanding endoprosthesis For use in hemodialysis patients for the treatment of stenosis or occlusion within central veins as well as the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft Received the CE mark
Orteq Sports Medicine Ltd., of London Actifit Synthetic implantable scaffold made of a biocompatible and biodegradable polymer Preserves the knee joint and promotes new tissue growth in damaged areas of an irreparable meniscus Received breakthrough device designation from the U.S. FDA
Royal Philips NV, of Amsterdam Philips Biosensor BX100 Wireless, wearable biosensor Monitors vital signs in hospital patients to detect deterioration Received 510(k) clearance from the U.S. FDA
Smart Medical Systems Ltd., of Ra'anana, Israel G-Eye Colonoscope with balloon Detects cancerous polyps Received 510(k) clearance from the U.S. FDA
United Imaging Healthcare Co. Ltd., of Shanghai Umr Omega Magnetic resonance imaging scanner with 75-cm bore Produces diagnostic images Received 510(k) clearance from the U.S. FDA

Notes

For more information about individual companies and/or products, see Cortellis.

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