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.
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.
With the lack of public trust and confidence the biggest barrier to SARS-CoV-2 vaccines in the U.S., the risk of granting an emergency use authorization to a vaccine with safety issues or questionable efficacy could destroy confidence in future FDA-approved products. That message was drummed home throughout the Oct. 22 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.
Keeping you up to date on recent developments in diagnostics, including: Study underscores long-term impact of COVID-19; CT scan enhancement via deep learning; Caution in screening for large fetus size.
The U.S. FDA’s recent decision to pass on any emergency use authorization (EUA) filings for tests for the COVID-19 pandemic is well known, but the agency had a chance to lend some additional information on that question in the Oct. 21 town hall. Despite the opportunity to clarify some of the underlying questions, Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health (OIR), said little more than that the change was made “largely because the FDA cannot require an EUA, according to the HHS statement.”
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