Company Product Description Indication Status
3D Systems Inc., of Rock Hill, S.C. Vantage Ankle PSI Patient-specific total ankle surgical planning and 3D-printed instruments Guides resections in the tibia and talus for total ankle replacement surgery using Exactech's Vantage total ankle system Received 510(k) clearance from the U.S. FDA
Allotrope Medical Inc., of Houston Stimsite Device provides electrical stimulation to ureter smooth muscle tissue Helps locate and identify ureters for surgery Received 510(k) clearance from the U.S. FDA
Co-Diagnostics Inc., of Salt Lake City Logix Smart ABC Multiplex test that uses Coprimer technology; for use with saliva and other respiratory tract samples For simultaneous detection of and differentiation between influenza A, influenza B and SARS-CoV-2 Received CE-IVD marking
Co-Diagnostics Inc., of Salt Lake City Logix Smart SARS-CoV-2 Multiplex test that uses Coprimer technology; for use with saliva and other respiratory tract samples Uses 2 gene markers (RdRp and E-gene) to identify the presence SARS-CoV-2 Received CE-IVD marking
Hologic Inc., of Marlborough, Mass. Genius Digital Diagnostics system Digital cytology platform that combine an artificial intelligence algorithm with advanced digital imaging Helps cytotechnologists and pathologists identify precancerous lesions and cancer cells in women Received the CE mark
Safkan Inc., of Seattle Otoset Automated ear cleaning device Removes impacted earwax Received 510(k) clearance from the U.S. FDA
Sommetrics Inc., of Vista, Calif. Aersleep II Self-contained, portable unit with an integral vacuum pump; the unit is held in place without the need for a retaining strap Applies negative pressure over the external surface of the neck to hold the airway open during sleep in people with sleep apnea Received breakthrough device designation from the U.S. FDA
Tissium SA, of Paris Vascular sealant Biocompatible polymer For achieving hemostasis and preventing post-operative bleeding following peripheral vascular surgeries Received approval from the U.S. FDA for its investigational device exemption application

Notes

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