Company Product Description Indication Status
Apyx Medical Corp., of Clearwater, Fla. Renuvion Delivers helium plasma For skin laxity procedures in the neck and submental region Received approval from the U.S. FDA to begin phase II of its IDE clinical study
Braid Health Inc., of San Francisco Braid mobile application Artificial intelligence-based diagnostic collaboration software Lets providers and radiologists access, review and annotate images as well as share results with patients in real time, from any mobile device Received U.S. FDA clearance
Cardiawave SA, of Paris Valvosoft Delivers focused ultrasound Treatment of aortic stenosis Received authorization from the French National Agency for Health Products Safety to extend its clinical trial in France; up to 20 new patients are expected to be treated
Cepheid Inc., of Sunnyvale, Calif. Xpert Xpress SARS-CoV-2/Flu/RSV Rapid molecular diagnostic test For the qualitative detection of the viruses causing COVID-19, flu A, flu B and RSV infections from a single patient sample Received CE-IVD marking
Fluidigm Corp., of South San Francisco, and Premas Life Sciences Pvt. Ltd., of Delhi, India Advanta Dx SARS-CoV-2 RT-PCR Assay Extraction-free saliva-based test Detects nucleic acid from the SARS‑CoV‑2 virus The Central Drugs Standard Control Organisation in India has licensed importation and commercial sale
Neuronetics Inc., of Malvern, Pa. Touchstar treatment protocol 3-minute intermittent theta burst (iTBS) protocol for the Neurostar Advanced Therapy system Treatment of major depressive disorder Received U.S. FDA clearance
Zymo Research Corp., of Irvine, Calif. Quick-DNA/RNA Viral Magbead Kit Used with Zymo Research's DNA/RNA Shield For high-throughput purification of viral DNA and/or RNA from biological samples Received CE-IVD marking

Notes

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