Company Product Description Indication Status
Cepheid Inc., of Sunnyvale, Calif. Xpert Xpress SARS-CoV-2/Flu/RSV Rapid molecular diagnostic test for use on the Genexpert systems For the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus, influenza B virus and respiratory syncytial virus (RSV) Received emergency use authorization from the U.S. FDA
Conformis Inc., of Billerica, Mass. Cordera hip system Uncemented, primary total hip replacement composed of femoral and acetabular components; can be used with with optional patient-specific instrumentation and personalized surgical plan For use in total hip replacement due to: a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or congenital hip dysplasia; treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement; revision procedures for failed previous hip surgery Received 510(k) clearance from the U.S. FDA
Guide Sensmart Tech Co. Ltd., of Nuremberg, Germany IR236 IR fever warning system Automated infrared thermal imaging system Enables temperature screening in crowded public places to detect people with a potential fever and contain or limit the spread of SARS-CoV-2 Health Canada authorized as a medical device for uses related to COVID-19
Oxford Immunotec Global plc, of Abingdon, U.K. T-spot.TB test Single-visit blood test For tuberculosis (TB) screening Received clearance from the U.S. FDA to amend the pediatric age limitation to allow use in individuals 2 years of age and older
Surgical Innovation Associates Inc., of Chicago Durasorb Absorbable monofilament mesh For reconstructive and aesthetic indications, including abdominal hernia prophylaxis, breast tissue support, and prosthetic breast support Received the CE mark

Notes

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