In a highly anticipated article, FDA officials Vinay Prasad, M.D., and Martin Makary, M.D., outlined a novel regulatory ...
Integrating Git version control with validation systems automates medical device software traceability, ensuring instant ...
On track to submit GraftAssureDx™ for FDA review by year-endOn track for commitment to have 20 transplant centers globally ...
SAN FRANCISCO--(BUSINESS WIRE)--Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced today that the U.S. Food and Drug ...
Market opportunities lie in modernizing software development and validation approaches, emphasizing agility and continuous validation to meet changing needs, while ensuring compliance with FDA ...
The burgeoning field of Software as a Medical Device (SaMD) offers opportunities for innovation in healthcare monitoring and delivery through mobile apps. Regulatory focus by the FDA on "device ...
Market opportunities arise from the growing need for modernization and compliance assurance in FDA-regulated industries focusing on data integrity. Emphasizing cloud computing, automation, and mobile ...
FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...
The "Master Validation Plan - The Unwritten Requirements Course (November 18, 2025)" training has been added to ResearchAndMarkets.com's offering. FDA Warning Letters and recent high-profile recalls ...
The Food and Drug Administration has identified more cookware that could be leaching lead into your food, it said in an expanded warning updated on Oct. 15. The FDA published an initial notice on Aug.
Amid the chaos of the Trump administration’s haphazard job cuts and a mass exodus of leadership, the Food and Drug Administration is experiencing a slowdown of drug reviews and approvals, according to ...
What Is Rybelsus, and Why Does It Matter? Rybelsus (semaglutide) is a once-daily pill used to help lower blood sugar in adults with type 2 diabetes (T2D). It belongs to a group of medicines called GLP ...
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