Company Product Description Indication Status
7D Surgical, of Toronto Machine-vision Image Guided Surgery (MvIGS) system Image guidance system that uses camera-based technology and machine-vision algorithms For spine surgery Received the CE mark
Abiomed Inc., of Danvers, Mass. Automated Impella Controller External console used with Impella heart pumps For certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions Received U.S. FDA approval for one-way digital data streaming from the Impella console
Invo Bioscience Inc., of Sarasota, Fla. Invocell Assisted reproductive technology; device promotes in vivo conception and early embryo development Used in the treatment of infertility Received product registration approval in Turkey
M.I. Tech Co. Ltd., of Pyeongtaek, South Korea Hanarostent Esophagus Through the Scope stent Self-expanding metal stent to help achieve luminal patency For application in palliative treatment of esophageal stricture and/or trachea-esophageal fistula caused by malignant tumors Received 510(k) clearance from the U.S. FDA
Todos Medical Ltd., of Rehovot, Israel, and 3D Medicines Corp., of Shanghai COVID-19 qPCR test kits and extraction systems Molecular diagnostic Detects SARS-CoV-2 Received authorization from the Brazilian Health Surveillance Agency (ANVISA)

Notes

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

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