Company Product Description Indication Status
Access Genetics LLC (dba OralDNA Labs), of Eden Prairie, Minn. Orarisk COVID-19 RT-PCR Test Molecular diagnostic For the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab and nasal swab specimens Received emergency use authorization from the U.S. FDA
Boston Scientific Corp., of Marlborough, Mass. Watchman Flx Left atrial appendage closure device Reduces the risk of stroke in patients with non-valvular atrial fibrillation who need an alternative to oral anticoagulation therapy by permanently closing off the left atrial appendage Received U.S. FDA approval
Channel Medsystems Inc., of Emeryville, Calif. Cerene Cryotherapy device Treatment of heavy menstrual bleeding in the office setting Received U.S. FDA approval
Lifesignals Group Inc., of Fremont, Calif. Lifesignals Wireless Medical Biosensor LP1250 Single-use patch device with wireless remote monitoring system; allows for 72 hours of data capture For continuous collection of electrocardiography and heart rate monitoring in ambulatory, hospital, home and health care settings Received 510(k) clearance from the U.S. FDA
Paige Inc., of New York Fullfocus Digital pathology image viewer Allows in vitro diagnostic use of Fullfocus with FDA-authorized Philips Ultra Fast Scanner; assists pathologists in primary diagnosis Received 510(k) clearance from the U.S. FDA

Notes

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