Company Product Description Indication Status
Acutus Medical Inc., of Carlsbad, Calif. Acqcross Full suite of universal transseptal crossing devices For use in left atrium electrophysiology and structural heart procedures Received 510(k) clearance from the U.S. FDA
Hemanext Inc., of Lexington, Mass. Hemanext One System limits oxygen and carbon dioxide levels in the storage environment For the processing and storage of red blood cells to be used in transfusion therapy Received the CE mark
Lumiradx UK Ltd., of London Lumiradx SARS-CoV-2 RNA Star Complete Molecular diagnostic that uses qSTAR amplification Qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens Received reissued FDA emergency use authorization to include improved limit of detection and additional PCR system validations

Notes

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