Company Product Description Indication Status
Abbott Laboratories, of Abbott Park, Ill. Binaxnow COVID-19 Ag Card Rapid test Detection of COVID-19 infection U.S.FDA has issued emergency use authorization
B. Braun Medical Inc., of Bethlehem, Pa. Spacestation MRI Infusion pump shield To allow Space infusion pumps to continuously deliver medications to patients within the magnetic resonance imaging suite U.S. FDA granted clearance
Cureapp Inc., of Tokyo Cureapp SC Nicotine Addiction Treatment App and CO Checker Digital therapeutic To aid patients who are receiving outpatient smoking cessation treatment Received regulatory authorization from the Ministry of Health, Labour and Welfare
Foundation Medicine Inc., of Cambridge, Mass. Foundationone Liquid CDx Pan-tumor liquid biopsy test For reporting genomic alteration results across all solid tumors; for identifying patients who may benefit from treatment with specific FDA-approved targeted therapies, including an indication for Rubraca (rucaparib) in patients with BRCA 1/2-mutant metastatic castration-resistant prostate cancer and Iressa (gefitinib), Tagrisso (osimertinib), and Tarceva (erlotinib) in patients with non-small-cell lung cancer U.S. FDA granted approval
Healeon, a wholly owned subsidiary of Bimini Health Tech, of Solana Beach, Calif. Healeon Duet Blood separation system For platelet-rich plasma preparation U.S. FDA granted clearance
Med-El USA, of Durham, N.C. Rondo 3 Hearing device Audio Processor for the Synchrony Cochlear Implant System U.S. FDA granted approval
Sanuwave Health Inc., of Suwanee, Ga Dermapace System Shock wave device To treat diabetic foot ulcers Received approval from the Brazilian Agência Nacional de Vigilância Sanitária

Notes

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