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 ...

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 ...

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 ...

to achieve their intended medical purpose are known as machine learning-enabled medical devices (MLMD). "Medical purpose" refers to parts (a) through (e) of the "device" definition within the Food and ...

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 ...

LIFE SAVING MEDICAL DEVICE SYSTEMS. THIS IS A CRITICAL CARE LINE. THIS IS WHERE WE MAKE OUR BLOOD GAS ANALYZERS. MARK OLSON IS THE CHIEF MANUFACTURING OFFICER FOR WARFARIN. THIS MASSACHUSETTS ...

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 ...