While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...

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 ...

FDA 2025 pulmonology drug alerts, including drug approvals/warnings, vaccine approvals, and medical device recalls/updates.

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

But in the world of medical devices, these things often stay ... Cardiac devices dominate the list of reports to the Food and Drug Administration of deaths and injuries. Here are three devices ...

Brenner, who has worked in the FDA’s Center for Devices and Radiological Health, will lead the agency until a permanent ...

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.

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how ...

To address these shortages, the FDA has put measures into place, including expedited review processes and the use of enforcement discretion. The FDA also now requires manufacturers to give at least ...

TAVIPILOT Soft is said to be a ‘world-first’ provision for real-time surgical guidance during TAVI and TAVR procedures.