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