The U.S. Food and Drug Administration has pulled draft guidance from its website requiring companies to test medicines and ...

Brenner, who worked in the FDA’s Center for Devices and Radiological Health, will take the helm of the agency until a new ...

NeurAxis has seen significant developments, including expanded FDA clearance, increased insurance coverage, and a new ...

If you have a microcurrent device on your wishlist, here are some benefits and drawbacks to consider before you buy one.

Following the Trump administration's DEI ban, the FDA's move to scrub webpages has ensnared many pages focused on ensuring ...

Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line, even ...

After a close call with a Dekalb County deputy, Sheriff Nick Welden and other county leaders are taking strides to ensure the ...

The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...

New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain ...

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued ...

By establishing coding and separate payment for certain digital mental health devices, this group from CMS and the FDA hopes ...

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...