The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.

In 2023, the Food and Drug Administration (FDA) took a more active approach to medical device cybersecurity. They issued new requirements for premarket submission and ongoing monitoring by medical ...

The Flow FL-100 headset, recently cleared by the FDA, uses a low electrical current to stimulate a part of the brain involved in mood regulation. The Flow FL-100 was recently okayed by the U.S. Food ...

Jan 6 (Reuters) - The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed to support healthy lifestyles, issuing new guidance to ...