Dr. Marty Makary, a professor at Johns Hopkins University, is the latest Trump nominee who has declared the U.S. health ...

The Digital Health Advisory Committee (DHAC) held its first meeting to offer guidance to the FDA on a slew of questions ...

The Center for Devices and Radiological Health’s pilot program is meant to cut the time between the FDA’s awareness of ...

Center for Devices and Radiological Health (CDRH) is initiating a pilot centred on improving the timeliness of communications ...

Partner content with ISACA. FDA studies have found that in the medical device industry, compliance alone is not enough to ensure improved quality indicators. Why? Because compliant medical-device ...

Yes, blood tests for Alzheimer’s disease are ready for prime time. So pronounced Suzanne Schindler, Washington University, St. Louis, in a keynote presentation at CTAD 2024 last month in Madrid. In ...

Novocure (NASDAQ: NVCR) announced today that the U.S. Food and Drug Administration (FDA) approved its new Head Flexible Electrode (HFE) transducer arrays for use with Optune Gio® for the treatment of ...

The heart surgeon turned TV star has championed healthy lifestyle habits. But he’s also promoted sham diet pills and ...

The U.S. Food and Drug Administration will focus on “Total Product Lifecycle Considerations for Generative AI-Enabled Devices” during its ...

The FDA will discuss a new framework for regulating generative artificial intelligence (GenAI)-enabled medical devices.

The MiDe systems, inspired by squid propulsion, demonstrate effective needle-free drug delivery in the gastrointestinal tract ...

The Fabricators and Manufacturers Association (FMA) has announced a closer working relationship with the Food and Drug ...