Company Product Description Indication Status
Clinical Enterprise Inc., of Luxembourg Empowerdx COVID-19 Home Collection Kit Home COVID-19 nasal PCR kit SARS-CoV-2 FDA granted EUA
Fluidigm Corp., of South San Francisco Azova COVID-19 Test Collection Kit For use with the Fluidigm Advanta Dx SARS-CoV-2 RT-PCR Assay on the company's Biomark HD platform SARS-CoV-2 FDA granted EUA
Invo Bioscience Inc., of Sarasota, Fla. Invocell In vivo intravaginal culture system Infertility Mexico's Federal Committee for Protection from Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios) approved the importation of Invocell
Memic Innovative Surgery Ltd., of Tel Aviv, Israel, and Fort Lauderdale, Fla. Hominis Robot-assisted surgical platform Single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures including benign hysterectomy FDA granted de novo marketing authorization
Mobidiag Ltd., of Espoo, Finland Amplidiag RESP-4 molecular diagnostic test Simultaneous detection of some of the most prevalent respiratory viruses SARS-CoV-2, influenza A, influenza B and RSV Received CE-IVD marking
Opgen Inc., of Gaithersburg, Md. Curetis Unyvero System In vitro diagnostics Pneumonia requiring hospitalization China's NMPA granted approval
Perimeter Medical Imaging AI Inc., of Toronto Optical Coherence Tomography Imaging System (v2.1) Used to examine tissue microstructures during surgery Real-time margin visualization FDA granted marketing clearance
Vascular Grafts Solutions Ltd., of Tel Aviv, Israel Viola Clampless proximal anastomosis Coronary artery bypass grafting FDA granted marketing clearance
Vetex Medical Ltd., of Galway, Ireland Revene Thrombectomy Catheter De-clots peripheral vessels Deep vein thrombosis FDA granted marketing clearance

Notes

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