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 ...

Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...

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 ...

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 ...

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 ...