Company Product Description Indication Status
Abbott Laboratories, of Abbott Park, Ill. Advisedx SARS-CoV-2 IgM Lab-based serology test for use on the Architect and Alinity platforms Detects Immunoglobulin M (IgM) antibodies to SARS-CoV-2 Received emergency use authorization from the U.S. FDA
Cartiheal Ltd., of Kfar Saba, Israel Agili-C Cell-free, off-the-shelf implant For the treatment of cartilage lesions in arthritic and non-arthritic joints U.S. FDA granted breakthrough device designation
GE Healthcare, of Chicago Vivid Ultra Edition Artificial Intelligence-based ultrasound system For use in cardiovascular diagnostic exams Received 510(k) clearance from the U.S. FDA
Varian Medical Systems Inc., of Palo Alto, Calif. Flash therapy Experimental treatment modality delivering radiation therapy at ultra-high dose rates Noninvasive treatment option for patients with cancer Received an investigational device exemption from the U.S. FDA to initiate the FeAsibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases (FAST-01)

Notes

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