Company Product Description Indication Status
Helius Medical Technologies Inc., of Newtown, Pa. Portable Neuromodulation Stimulator (PoNS) device Mouthpiece delivers mild electrical stimulation to the surface of the tongue Short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis Received marketing authorization from the U.S. FDA via the de novo pathway
Medtronic plc, of Dublin Harmony transcatheter pulmonary valve (TPV) system Non-surgical heart valve Treats pediatric and adult patients with a native or surgically repaired right ventricular outflow tract; Improves blood flow to the lungs in patients with severe pulmonary valve regurgitation without open-heart surgery Received premarket approval from the U.S. FDA via breakthrough device designation
Qiagen NV, of Hilden, Germany Neumodx Flu A-B/RSV/SARS-CoV-2 Vantage assay RT-PCR test Simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, influenza B virus, and/or respiratory syncytial virus (RSV) RNA Received emergency use authorization from the U.S. FDA
STS Lab Holdco (a subsidiary of Services LLC), of Seattle Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 RT-PCR test to be used with Amazon COVID-19 Test Collection Kit Qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens that are self-collected by any individual; for use in pooled samples containing up to 5 individual specimens per pool Received emergency use authorization from the U.S. FDA


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