Recalls of home-based medical devices and defective single-use devices are the top two concerns on the Pennsylvania-based non-profit's top 10 technology hazards for 2023. The growing popularity of ...

The number of medical devices with artificial intelligence technology has risen sharply in the past decade. The Food and Drug Administration has authorized 950 AI or machine learning-enabled devices ...

The FDA has quietly authorized more than 1,000 medical devices incorporating artificial intelligence or machine learning, marking a significant growth of AI in healthcare. The agency’s AI/ML-Enabled ...

Yesterday, the U.S. Food and Drug Administration (FDA) shared online its list of artificial intelligence and machine learning (AI/ML)-enabled devices that are legally marketed in the U.S. (via 510(k) ...

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 ...

Aging in place can be made safer with the help of assistive technology. We’ve put together a list of the top in-home ...

On May 20, 2021, FDA published a document (“Safety of Metals and Other Materials Used in Medical Devices”) requesting input regarding the best methods to use in conveyance of material information for ...

The agency also changed some of the categories for the list, which includes the reason the supply is in shortage and gives an estimate on how long the shortage is expected to last. Also included on ...

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 ...

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 ...