Company Product Description Indication Status
Conformis Inc., of Billerica, Mass. Itotal Identity PS Knee system Uses proprietary advanced imaging and design software to deliver a patient-specific, pre-operative surgical plan with a comprehensive set of Ijig instruments and patient-matched implants For knee replacement Received 510(k) clearance from the U.S. FDA
Mainstay Medical Holdings plc, of Dublin Reactiv8 Implantable neurostimulation system Treats intractable chronic low back pain Received premarket approval from the U.S. FDA
Medtronic plc, of Dublin Evolut Transcatheter aortic valve implantation (TAVI) system For heart valve replacement Received CE mark for expanded indication to treat severe native aortic stenosis patients at low risk for surgical mortality; also received a new indication approval for the treatment of patients with bicuspid aortic valves who are at intermediate, high and extreme risk of surgical mortality
Omnipathology Medical Solutions Corp., of Pasadena, Calif. Omni COVID-19 Assay by RT-PCR Molecular diagnostic for use on the BD Max platform; provides 24-hour turnaround For the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, nasopharyngeal wash/aspirate, nasal aspirate, and bronchoalveolar lavage specimens Received emergency use authorization from the U.S. FDA


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

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