The U.S. FDA has granted breakthrough device designation status to Medtronic plc’s Tyrx absorbable antibacterial driveline wrap, a medical device aimed at reducing driveline complications in patients receiving a ventricular assist device (VAD).
HONG KONG – Seoul, South Korea-based Vuno Inc. reported that it plans to list on South Korea’s Kosdaq bourse either by the end of 2020 or early next year, CTO and cofounder Kyu-hwan Jung told the 2020 Bioplus Interphex Korea Conference. After receiving A ratings in the recent technology evaluations by assessment institutions NICE D&B and Korea Enterprise Data, Vuno submitted a preliminary examination application to the bourse on July 28 that is currently underway, the company said.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Capsovision, Orbusneich, Surmodics, Urotronic.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accenture, Angle, Ardigen, Bioclinica, Caresafely, Change Healthcare, Cpsi, Ebamed, GI Reviewers, Longitude Capital, Medtronic, Quadvantage Technologies, Royal Philips, Thermo Fisher Scientific, Think Surgical, Total Joint Orthopedics.
Keeping you up to date on recent developments in orthopedics, including: Technology for printing customized neuroprostheses on a 3D bioprinter; AI could expand healing with bioscaffolds; AI detects osteoarthritis years before it develops; 'Bandage' developed to rebuild broken bone.
Before authorizing or licensing any COVID-19 vaccine, the U.S. FDA will hold a public advisory committee meeting on that vaccine, FDA Commissioner Stephen Hahn said at a Sept. 23 hearing before the Senate Health, Education, Labor and Pensions Committee.
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