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News about " Premarket Approval "
Artivion Secures US FDA Approval for AMDS Hybrid Prosthesis to Treat Acute Aortic Dissections
Artivion has received US FDA approval for its AMDS Hybrid Prosthesis, enabling broader adoption of the aortic arch remodelling device that has demonstrated significant reductions in mortality and major complications for patients with acute DeBakey Type I aortic dissections.
Premarket Approval | 01/07/2026 | By News Bureau
Grail Submits Final PMA Module to FDA for Galleri Multi-Cancer Early Detection Test
Grail files the final Premarket Approval module with the FDA for its Breakthrough Device-designated Galleri test, supported by data from over 25,000 participants in PATHFINDER 2 and the NHS-Galleri trial.
Premarket Approval | 30/01/2026 | By News Bureau | 502
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