Company Product Description Indication Status
Access Vascular Inc., of Bedford, Mass. Hydromid 4 French, single lumen, midline catheter made with proprietary biomaterial Reduces thrombus accumulation during intravenous therapy Received FDA clearance
Braincool AB, of Lund, Sweden Cooral system Intraoral device designed to specifically cool the area in the back of the mouth Prevention of oral mucositis in patients undergoing chemotherapy Received breakthrough device designation from the U.S. FDA
Brainq Technologies Ltd., of Jerusalem Artificial intelligence-powered electromagnetic field therapy Delivered via a cloud-connected wearable device Enhances recovery and reduces disability after neurological damage caused by stroke Received breakthrough device designation from the U.S. FDA
Cerus Endovascular Ltd., of Oxford, U.K. Contour neurovascular system Device composed of fine mesh braid that targets the neck of the aneurysm Treatment of intracranial aneurysms Received breakthrough device designation from the U.S. FDA
Genscript USA Inc., of Piscataway, N.J. Cpass SARS-CoV-2 Neutralization Antibody Detection kit Blocking ELISA detection assay Detects COVID-19 neutralizing antibodies without the use of live virus The U.S. FDA expanded emergency use authorization to allow use in convalescent plasma screening
Limacorporate SpA, of Udine, Italy Smart Space 3D Virtual Planner Software Supports surgeons on pre-operative case evaluation and intra-operative management Received the CE mark for the Mac OS version
Roche Group, of Basel, Switzerland Cobas BKV test Real-time PCR test that runs on the Cobas 6800/8800 systems Detects BK polyomavirus Received 510(k) clearance from the U.S. FDA to use stabilized urine samples
Techmah Medical LLC, of Knoxville, Tenn. Smart Space Humeral 3D Positioner Patient-specific 3D positioners that are identifiable on preoperative CT scans For use in total shoulder arthroplasty Received 510(k) clearance from the U.S. FDA
Techmah Medical LLC, of Knoxville, Tenn. Smart Space Shoulder Cubit Guidance Implantation assistance devices For use in total shoulder arthroplasty Received 510(k) clearance from the U.S. FDA

Notes

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