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CSA Medical submits application to FDA for RejuvenAir System
The system aims to address underlying chronic cough and issues with mucus production and clearance in chronic bronchitis.
Company on Track to File the 5 th and Final Module in Q4 2024 IRVINE, CA / ACCESSWIRE / August 14, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new ...
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 ...
"The FDA PMA submission is a major milestone – our first regulatory approval application for our AI-enabled wide-field OCT technology, as well as for a specific indication label," said Perimeter's ...
MORRISVILLE, N.C.--(BUSINESS WIRE)--Sapheon Inc. announced today that it submitted the first module of the pre-market approval (PMA) application for the VenaSeal® Sapheon Closure System to the U.S.
Cerus Announces FDA Agreement on Modular Premarket Approval Application (PMA) Submission Process for
CONCORD, Calif.--(BUSINESS WIRE)-- Cerus Corporation (NAS: CERS) announced today that the U.S. Food and Drug Administration (FDA) has accepted its proposed modular Premarket Approval application (PMA) ...
In a 5 to 1 vote today, the FDA Orthopaedic and Rehabilitation Devices advisory panel did not recommend approving Zimmer Spine’s premarket approval (PMA) application P070031 for marketing clearance of ...
MOUNT LAUREL, NJ - (NewMediaWire) - June 24, 2024 - United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company's FDA Premarket Approval (PMA) application process. Following the ...
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 ...
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 ...
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