Company Product Description Indication Status
Brainsway Ltd., of Jerusalem Deep TMS system Transcranial magnetic stimulation (TMS) device Treatment of major depressive disorder Received 510(k) clearance from the U.S. FDA for Theta Burst 3-minute protocol
Lucira Health Inc., of Emeryville, Calif. Lucira Check It COVID-19 test kit Molecular diagnostic for self testing For the qualitative detection of SARS-CoV-2 Received interim order authorization from Health Canada
Neurolutions Inc., of Santa Cruz, Calif. Ipsihand upper extremity rehabilitation system Includes a wearable robotic exoskeleton that is worn over the patient's hand and wrist, a tablet computer, and an EEG-based biometric headset For use in chronic stroke patients to facilitate muscle re-education U.S. FDA granted de novo market authorization
Phoenix Cardiac Devices Inc., of Cary, N.C. BACE Basal annuloplasty of the cardia externally (BACE) surgical device Treatment of functional mitral regurgitation Received the CE mark
Speedx Pty. Ltd., of Sydney Plexpcr SARS-CoV-2 2-gene test compatible with 96- or 384-well qPCR systems Detection of SARS-CoV-2 Received CE-IVD marking

Notes

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