Why Cresilon, Audicus, ivWatch, and GrayMatters Health are among Fast Company’s Most Innovative Companies in the medical device category for 2024. Healthcare is the backbone of society, but good ...

New Delhi: In an attempt to bring regulatory uniformity in medical devices, the government plans to classify around 1,178 medical devices into four categories based on their risk approach under the ...

Thanks to AI, we’re in the midst of an unprecedented technology boom. The medical devices industry hasn’t been left out of it. Among the 10 Most Innovative Companies in the medical device field, ...

Use of real-world evidence to support regulatory decisions and predetermined change control plans for medical devices are two ...

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...

Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. The healthcare landscape has changed dramatically since I first entered a surgical suite in ...

CHICAGO--(BUSINESS WIRE)--On a recently updated FDA list of artificial intelligence (AI) enabled medical devices, GE Healthcare had the highest number of authorizations, with 42 listed 510(k) ...

Ethics rules barred Dr. Jeffrey E. Shuren from working on matters involving clients of his wife’s law firm. But he did not always step aside. Dr. Jeffrey E. Shuren in 2022. He presided over the F.D.A.