The Chicago-based medical technology company said the MRI device, called Signa Magnus, had received 510(k) clearance by the U.S. Food and Drug Administration. That approval pathway is for devices that ...
With this approval, Aucatzyl enters a market that includes Gilead’s Tecartus, which gained FDA approval for B-ALL in 2021.
Detailed price information for Seastar Medical Hldg Corp (ICU-Q) from The Globe and Mail including charting and trades.
The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...
With FDA approval of an investigational device exemption, J&J’s soft tissue robot moves a step closer to challenging ...
The U.S. Food & Drug Administration has approved Johnson & Johnson's device for a type of condition which causes abnormal ...
The VARIPULSE™ Platform is the first and only Pulsed Field Ablation (PFA) System in the U.S. fully integrated with the CARTO™ ...
DENVER, Nov. 13, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device ... FDA deadline to begin patient ...
"By 2024, the market is projected to reach a staggering US$597.00bn worldwide. Among these markets, Medical Devices are expected to dominate, with a projected market volume of US$508.00bn by 2024.
The question is more urgent as over-the-counter continuous glucose monitoring devices become more widely available.
Robert F. Kennedy Jr., one of President-elect Donald J. Trump’s advisers on health, is taking aim at the agency’s oversight on many fronts.
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