|Axonics Modulation Technologies Inc., of Irvine, Calif.||Third-generation implantable neurostimulator (INS)||Enhancements include upgraded embedded software in the INS and the functionality of the patient remote control||Treats patients with urinary and bowel dysfunction via sacral neuromodulation||Received PMA supplement approval from the U.S. FDA|
|Electrocore Inc., of
Basking Ridge, N.J.
|Gammacore nVNS||Noninvasive, hand-held medical therapy applied at the neck that delivers mild electrical stimulation to the vagus nerve that passes through the skin||Acute and preventive treatment of migraine||Received expanded 510(k) clearance from the U.S. FDA to include adolescents between 12 and 17 years of age|
|Front Line Medical Technologies Inc., of London, Ontario||Control of bleeding, resuscitation, arterial occlusion system (COBRA-OS)||4 French aortic occlusion device||For temporary hemorrhage control and resuscitation||Received Health Canada approval|
|Insightec Ltd., of Tirat Carmel, Israel||Exablate 4000 (Exablate Neuro)||Uses MR-guided focused ultrasound to precisely ablate tissue deep within the brain without incisions||Treatment for essential tremor and tremor-dominant Parkinson's disease||Received market approval by the Brazilian Health Regulatory Agency, Anvisa|
|Luminostics Inc., of San Jose, Calif.||Clip COVID Rapid Antigen Test||Antigen lateral flow immunoluminescent assay for smartphone-based analyzer||Detects SARS-CoV-2 viral antigens from nasal swabs||Received emergency use authorization from the U.S. FDA|
|Saladax Biomedical Inc., of Bethlehem, Pa.||Mycare Psychiatry Laboratory Assays||5 in vitro diagnostic assays||Provides blood drug concentration levels for clozapine, risperidone, paliperidone, aripiprazole, olanzapine, and quetiapine||Received Health Canada approval|
|Shockwave Medical Inc., of Santa Clara, Calif.||Shockwave intravascular lithotripsy (IVL) system with Shockwave C2 coronary IVL catheter||Uses sonic pressure waves that pass through soft arterial tissue and preferentially disrupt calcified plaque by creating a series of micro-fractures||For lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting||Received U.S. FDA PMA for severely calcified coronary artery disease; was previously cleared for the treatment of peripheral arterial disease|
|Smart Medical Systems Ltd., of Ra'anana, Israel||G-eye Colonoscope||Colonoscope with balloon at its distal bending section||For use in endoscopy and endoscopic surgery within the lower gastrointestinal tract||Received additional 510(k) clearance from the U.S. FDA based on Fujifilm's colonoscopes; previously received clearance based on Pentax's colonoscopes|
For more information about individual companies and/or products, see Cortellis.