FDA uses a range of biocompatibility test data to evaluate medical devices before clearing or approving them for marketing. The growing use of FDA-recognized consensus standards facilitates this ...

The world of medical devices is growing more sprawling every day. Some promising novel ideas can take longer to wind their way through regulatory review and get to patients — so since 2017, the Food ...

The growing prevalence of chronic diseases like cancer and diabetes is driving increasing innovation in medical device ...

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 ...

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

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, ...

CHICAGO--(BUSINESS WIRE)--GE HealthCare has topped a U.S. Food and Drug Administration (FDA) list of artificial intelligence (AI) enabled medical devices with 58 listed 510(k) clearances or ...