Alpha Tau Completes Patient Enrollment in its U.S. Pivotal Skin Cancer Study, Advancing Towards Goal of FDA Approval of Alpha DaRT® to Treat Recurrent Cutaneous Squamous Cell ...

First U.S. pivotal study for Alpha Tau to have completed enrollment, representing a critical milestone on the path towards potential FDA ...
Nasdaq

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 ...

Galaxy Therapeutics Submits Final Module of PMA to U.S. FDA for SEAL™ Device in Wide-Neck Bifurcation Aneurysms

Galaxy Therapeutics, a privately held, clinical-stage medical device company focused on treating brain aneurysms, today announced the submission of its final module of its Premarket Approval (PMA) ...
Regulatory Affairs Professionals Society

FDA cites firms for CGMP violations, failure to submit PMA application

The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good ...
Business Wire

Evolus Announces Submission of Premarket Approval Application to the U.S. Food and Drug Administration for Evolysse™ Sculpt Injectable Hyaluronic Acid Gel Product

NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today announced that it has ...
Seeking Alpha

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 ...
Sacramento Bee

enVVeno Medical Submits the VenoValve PMA Application Seeking FDA Approval

Company to Host a Conference Call with the PIs Presenting the Pivotal Trial Data on Wednesday, November 20 th at 2:00 PM Eastern Time - Click Here to Access IRVINE, CA / ACCESSWIRE / November 19, 2024 ...
RAPS

PMA Application to be Required for Controversial Hip Devices, Says FDA

The US Food and Drug Administration (FDA) has proposed a new rule that would classify all hip joint metal-on-metal semi-constrained prosthesis with either cemented or un-cemented acetabular components ...
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 ...
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 ...