The cuts at the FDA’s device center could add “months, if not years” to the time it takes to bring products to market, an ...

Ezra, the healthcare AI startup revolutionizing early cancer detection through full-body MRI screening, today announced new 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its ...

A list with the file name "Prohibited words" has been circulating since at least last week in official work chats, according ...

The CEO of the medical device lobby, AdvaMed, raised concerns over the cuts' impact on patient health and medical device innovation. Separately, the former administrator of CMS spoke up to caution ...

2025 – The FDA has approved a new wearable device ... highlighting the need for continuous relief. Onapgo is a small lightweight device that delivers apomorphine directly into the bloodstream ...

The designation reflects the FDA’s determination that the device is reasonably expected to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating ...

the settings within the mobile medical app connected to the diabetes device must be configured correctly with the settings within the smartphone itself. To mitigate this issue, the FDA is ...

Valencia-based Avita Medical Inc. has received FDA approval for a version of its second-generation Recell skin cell harvesting device designed to treat small-scale wounds. Avita’s original ...

In early November, Emily James, 27, of Kansas City, Missouri, underwent a most unusual and expensive ($17,000) body-altering surgery, the New York Post... Main Office 570-387-1234 ...

Sara Brenner, a Food and Drug Administration official in the agency’s medical device division, has been named the FDA’s acting commissioner, according to an update made online to the regulator ...

The FDA's Diversity Action Plan draft guidance to drug and medical device companies stems from the 2022 Food and Drug Omnibus Reform Act. It aims to significantly increase participation of ...