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