Heart disease, also called cardiovascular disease, can have serious consequences. It's the leading cause of death for adults in the U.S. Medical devices approved by the U.S. Food and Drug ...

In the medical device industry, FDA inspections are not a regulatory hurdle — they are a powerful tool for improving product ...

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 ...

a supplier of aftermarket medical imaging parts and services. Richardson Electronics also entered into an exclusive 10-year global supply agreement with San Diego-based DirectMed in which ...

The Food and Drug Administration signs off on a new wound treatment device by Avita Medical. Tech: Avita's Recell. Valencia-based Avita Medical Inc. has received FDA approval for a version of its ...

This study demonstrated that a small wearable device accurately predicted the DaTscan result at the individual level in RT patients, based on tremor inertial features. A strength of this study is its ...

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The FDA's Diversity Action Plan draft guidance to drug and medical device companies stems from the 2022 Food and Drug Omnibus Reform Act.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