Connected medical devices improve patient care but introduce severe cybersecurity risks that require stringent regulatory ...
Medical device lobbyists called for more staffing transparency in user fee negotiations with the Food and Drug Administration ...
After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...
Synergy Spine Solutions has received PMA from the FDA for the Synergy Disc, expanding cervical disc replacement options for US patients.
The DCB currently remains an investigational device and is not available for sale in the US. "Airiver Medical receives FDA ...
Four major wearable tech companies are advancing blood pressure monitoring capabilities despite FDA warnings about medical ...
Medical Device Network on MSN
FDA grants breakthrough designation to PathAI for pathology solution
The latest milestone follows PathAI’s 510(k) clearance for AISight Dx, the first FDA-approved digital pathology system.
FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed on Oct. 14, 2015. (AP Photo/Andrew Harnik, File) WASHINGTON (AP) — Barely a week after mass firings at the ...
On July 31, 2025, the U.S. Food and Drug Administration (FDA) issued its final guidance document “Medical Device User Fee Small Business Qualification and Determination,” which supersedes its previous ...
FDA clears tool predict delivery date using AI to analyze ultrasound images and support clinical decisions in pregnancy care.
The Food and Drug Administration is investigating how a contracted document management company accidentally made public 75,000 pages of confidential FDA files related to approval of medical devices, ...
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