Company Product Description Indication Status
Becton, Dickinson and Co. (BD), of Franklin Lakes, N.J. BD Veritor system for Rapid detection of SARS-CoV-2 assay Rapid, point-of-care antigen test for use on the BD Veritor Plus system Detection of proteins from SARS-CoV-2 Received the CE mark
Genetron Holdings Ltd., of Beijing HCCscreen Blood-based next-generation sequencing test For early detection of hepatocellular carcinoma (HCC) in individuals who are designated to be at high-risk for HCC due to chronic HBV infection and/or liver cirrhosis Received breakthrough device designation from the U.S. FDA
Ka Imaging Inc., of Waterloo, Ontario Reveal 35C Portable dual-energy X-ray detector; simultaneously delivers digital radiography, bone, and tissue images in one shot Enables bone and soft-tissue differentiation without motion artifacts in a single X-ray exposure Received a medical device license from Health Canada
Perkinelmer Inc., of Waltham, Mass. Eonis RT-PCR newborn screening assay Simultaneously tests for spinal muscular atrophy, severe combined immunodeficiency and X-linked agammaglobulinemia in newborns Received CE-IVD approval
Sentiar Inc., of St. Louis Commandep Receives imaging data from the electroanatomic mapping systems and creates a 3D holographic image to be presented via a wearable headset Allows electrophysiologists to visualize 3D electroanatomic models and navigate accurately within the heart during a cardiac ablation procedure Received 510(k) clearance from the U.S. FDA
Vexos Inc., of New York Mechanical Ventilator Milano (MVM) Electrically operated, microprocessor controlled, pneumatically driven ventilator Treatment of adult patients suffering from respiratory failure due to COVID-19 who require temporary or longer-term invasive ventilatory support Health Canada approved the MVM for use under interim order


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