GRAIL Submits FDA Premarket Approval Application for the Galleri® Multi-Cancer Early Detection Test

GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced the submission of the final module of the Premarket Approval (PMA) ...
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United Health Products provides update on PMA application

United Health Products (UEEC) provided an update on the company’s FDA Premarket Approval application process. Following the company’s August 15, 2024 submission of its Submission Issue Request to the ...
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Sequana Medical announces FDA acceptance for substantive review of the Premarket Approval application for alfapump® in recurrent or refractory ascites due to liver cirrhosis

Acceptance and filing review is a first step in the PMA review process Indicates PMA application is sufficiently complete for in-depth review Received in advance of anticipated timing Ghent, Belgium – ...
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Perimeter Files FDA PMA Application for its Next-Generation B-Series OCT with ImgAssist AI 2.0

TORONTO and DALLAS, March 17, 2025 /CNW/ - Perimeter Medical Imaging AI, Inc. (PINK:CA) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, today announced ...
Nasdaq

NVCR Stock Slips Despite PMA Application to Treat Pancreatic Cancer

NovoCure Limited NVCR, on Wednesday, announced its submission of a premarket approval (PMA) application to the FDA for Tumor Treating Fields (TTFields) therapy for the treatment of locally advanced ...
Seeking Alpha

United Health Products Provides Update on FDA PMA Application

MOUNT LAUREL, N.J., Nov. 04, 2024 (GLOBE NEWSWIRE) -- United Health Products, Inc. (UEEC) today provided an update on the company’s FDA Premarket Approval (PMA) application process. Following the ...