Company Product Description Indication Status
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

Notes

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