The Food and Drug Administration Feb. 5 released an alert notifying patients of a safety concern using diabetes devices such ...

While the brand originally initiated the recall in December, the FDA just recently classified the recall as a Class II, meaning “a situation in which use of, or exposure to, a violative product ...

Specifically, a $149.99 LED face mask. The Nanoleaf LED Light Therapy Face Mask is made of medical-grade materials and has received FDA Class II device certification. (This doesn’t mean the FDA ...

The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release.

The future of medical devices has much potential, but they also have risks related to cybersecurity. In 2024, we saw the first full year of the Food and Drug Administration’s (FDA) new guidance ...

The US Food and Drug Administration has approved the use of a novel painkiller as an effective treatment for short-term moderate-to-severe pain in adults. It’s the first of a new class of ...

Steps 1 and 2 ... for devices with AI-enabled device software functions. This guidance fits within FDA’s Total Product Life Cycle (“TPLC”) approach to reviewing and monitoring medical ...