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 ...

The webinar highlights opportunities in enhancing system validation, utilizing agile and waterfall methodologies, and leveraging COTS, SaaS, IaaS, PaaS, and cloud solutions to meet FDA requirements ...

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 ...

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 ...

FOX 5 talked to a teen five years ago about a diabetes app in production. Now, the app has received FDA clearance. Trump administration looking to sell nearly 200 commissary stores Border Patrol ...

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.

The drug, one of the few nonhormonal options for menopausal women, reduced hot flashes and night sweats, and appears to help with sleep issues. By Nina Agrawal and Maggie Astor The Food and Drug ...