|Agilent Technologies Inc., of Santa Clara, Calif.||PD-L1 IHC 22C3 Pharmdx||Companion diagnostic||For use as an aid in identifying non-small-cell lung cancer (NSCLC) patients with tumor PD-L1 expression of Tumor Proportion Score (TPS) ≥ 50% for treatment with Libtayo (cemiplimab-rwlc, Sanofi SA/Regeneron Pharmaceuticals Inc.)||U.S. FDA approved expanded use in patients with NSCLC; previously approved to help select eligible cancer patients for treatment with Keytruda|
|Assure Tech (Hangzhou) Co. Ltd., of Hangzhou, China||COVID-19 Antigen Rapid Test Device (Ecotest)||Point-of-care fingerstick blood test||Detects SARS-CoV-2 antigens||Received Health Canada authorization|
|Assure Tech (Hangzhou) Co. Ltd., of Hangzhou, China||COVID-19 IgG/IgM Rapid Test Device (Ecotest)||Point-of-care fingerstick blood test||Detects SARS-CoV-2 antibodies||Received Health Canada authorization|
|Dascena Inc., of Oakland, Calif.||GI bleed risk alert system (Gibras)||Cloud-based software application that uses a machine learning algorithm to analyze patient electronic health record data||Aids in the early prediction of gastrointestinal bleeding in adult patients in a hospital setting||U.S. FDA granted breakthrough device designation|
|G21 Srl, of San Possidonio, Italy||Spaceflex Shoulder||Custom modular spacers with antibiotic-loaded bone cement||For arthroplasty revision in the operating room||Received 510(k) clearance from the U.S. FDA|
|Locate Bio Ltd., of Nottingham, U.K.||Chondro3||3 layered, collagen-based biodegradable matrix||Provides a scaffold for cellular and tissue in-growth and osteochondral defect repair at the site of lesion||U.S. FDA granted breakthrough device designation|
For more information about individual companies and/or products, see Cortellis.