Teleflex Inc. issued a recall of its Iso-Gard S filters for respiratory equipment due to reports of separation, a problem that could impede the delivery of oxygen to patients. The class I recall was driven by 36 complaints and four injuries reported to the U.S. FDA, and affects more than 60,000 units shipped between Sept. 1, 2020, and July 5, 2022.
It’s taken eight years of jury trials, court reversals and appeals for Amgen Inc. to get the nod to argue its case before the U.S. Supreme Court on what is needed to meet the enablement standard for functional patent claims that envelop a genus.
Verve Therapeutics Inc.’s heart disease candidate, VERVE-101, is the latest gene editing-based therapy to hit a snag at the FDA, which issued a clinical hold, delaying the start of phase I testing in the U.S. News of the hold, which followed preclinical presentations over the weekend at the American Heart Association 2022 meeting, sent shares of Verve (NASDAQ:VERV) falling 30.5% to close Nov. 7 at $21.75.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Astrazeneca, Iveric, Medincell, Moderna, Sanofi, Teva.
The U.S. FDA held a two-day advisory hearing in the last week of October 2022 to address some lingering regulatory questions, including the question of whether therapeutic nail prostheses should be a class I device. The potentially more dramatic shift, however, would be the application of a class III risk designation to tissue expanders used in breast surgery.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita Medical, Neurosteer.
The U.S. CMS had the usual mix of good news and bad news in its hospital outpatient final rule for calendar year 2023, which served up a plate of bad news for Brainscope Inc. and Elucent Medical Inc., which will enjoy no new technology pass-through (NTPT) payments in the coming year for their applications. Conversely, Carlsmed Inc. and Microtransponder Inc. both came out of the annual NTPT scrum with wins, thus ensuring they’ll be able to more rapidly recapture their med tech investments.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accelus, Fresenius Medical Care, Grifols, Orasure Technologies, Prosomnus.
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