Company Product Description Indication Status
Acutus Medical Inc., of Carlsbad, Calif. Acqcross Transseptal System Integrated family of transseptal crossing products Access to the left atrium CE Mark
Advanced Bionics LLC, of Valencia, Calif. Marvel Cochlear Implant Platform Hearing technology for adult and pediatric coclear implant wearers Hearing loss FDA approval
Advanced Medtech Holdings Pte. Ltd., of Singapore Resolute 2.0 test kit RT-PCR COVID-19 test Detection of SARS-CoV-2 infection Health Sciences Authority approval
Laboratory Corporation of America Holdings, of Burlington, N.C. Pixel by Labcorp COVID-19 Test Home Collection Kit At-home collection system for detection of SARS-CoV-2 infection Direct-to-consumer sale without a prescription FDA Emergency Use Authorization
Oxford Immunotec Global plc, of Oxford, U.K. T-Cell Select reagent kit Immune cell separation reagent Automate preparation of cells required to run the T-Spot.TB test for diagnosis of tuberculosis infection Ministry of Food and Drug Safety approval
Recor Medical Inc., of Palo Alto, Calif. Paradise Ultrasound Renal Denervation System Catheter-based system to denervate renal nerves with ultrasound energy Treatment of uncontrolled hypertension FDA breakthrough device designation
Virocule Inc., of Markham, Ontario Anosmic COVID-19 smell tester Spray-engineered device to detect change in smell perception COVID-19 at-home screening Health Canada authorization

Notes

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