Company Product Description Indication Status
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

Notes

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