EBR Systems has submitted the final module of its premarket approval (PMA) application to the FDA for its WiSE CRT System. EBR anticipates approval in Q1 CY25 and remains on track for commercial ...
Dublin, April 15, 2026 (GLOBE NEWSWIRE)-- The "Practical Guide to FDA Medical Device Submissions - 510(k), PMA and Exemption Pathways (Apr 14, 2026)" training has been added to ...
Mesquite, NV, March 29, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – United Health Products, Inc. (UEEC) today provided an update on the company’s FDA Premarket Approval application process. As ...
Imricor has achieved another key milestone with the second module for premarket approval of its devices submitted to the US FDA. Imricor Medical Systems (ASX:IMR) – which has developed the world’s ...
(MENAFN- GlobeNewsWire - Nasdaq) This seminar offers key market opportunities by enhancing understanding of FDA device regulatory processes, including 510(k), IDE, PMA, HDE, and De Novo applications.
The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good ...
EBR anticipates approval in Q1 CY25 and remains on track for commercial launch next year Special Report: EBR Systems has submitted the final premarket approval (PMA) application module to the US Food ...
Imricor Medical Systems (ASX:IMR) – which has developed the world’s only MRI-compatible devices for cardiac ablations – said the second module, focused on quality manufacturing processes, is ...
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