|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.