Abiomed Inc. has won the U.S. FDA’s nod for its Breethe Oxy-1 device, an all-in-one, compact cardiopulmonary bypass system designed for easy mobility. The company plans a controlled release at U.S. hospitals between now and March of 2021, with widespread availability later that year.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Medtronic advises of problems with Interstim leads; Palmetto eyes coverage of CT for cerebral perfusion.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Bio-Techne, Foldax, Foundation Medicine, Helix, Kantaro, Perkinelmer, Siemens Healthineers, Theranica.
Interest in testing the mettle of three widely available drugs against COVID-19 gained traction Monday, led by suggestions that daily low-dose aspirin might lower the risks of complications and death from the disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeglea, Bayer, Bioinvent, Bioxcel, Forte, Janssen, Nicox, Nitric Oxide Innovations, Passage, Santen, Sesen, Spectrum, Tracon, Y-mabs.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 1health.io, Arc Bio, Genesprint Group, Holo Surgical, IMEC, Infrawear, Remote Medical International, Royal Philips, Suralign Holdings, TÜV Rheinland.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Nuclear Regulatory Commission issues advisory letter to INIS; HHS authorizes pharmacy interns to test for COVID-19.
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