The layoffs had decimated the workforce that processes Freedom of Information Act requests across FDA centers.

The US Food and Drug Administration (FDA) has awarded Neuralink’s brain-computer interface breakthrough device designation ...

On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the ...

The US Food and Drug Administration (FDA) has approved Element Science’s premarket approval application for its Jewel Patch ...

Neuralink said on social media that it received FDA breakthrough device designation for treating individuals with severe ...

Neuralink has received the U.S. Food and Drug Administration's "breakthrough" tag for its device to restore communication for ...

The apparent reversals are the latest examples of the haphazard approach to agency cuts that have shrunk FDA’s workforce by ...

Element Science announced today that it received FDA pre-market approval for its Jewel patch wearable cardioverter ...

This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China, Brazil, Australia, and South Korea are approaching AI in medical devices.

Recent reorganizations and "reductions in force" at the FDA have damaged the very backbone of our public health system.

Spice is known as a synthetic marijuana, but can cause psychotic episodes, and inmates found a clever way to sneak Spice into ...