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 ...

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

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 ...

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 ...

Following a filing revealing its intent to go public in the US on 6 January, artificial pancreas maker Beta Bionics has now set its financial goalposts, aiming to raise $114.4m from the initial public ...

His work will contribute to ongoing efforts by the FDA to ensure the safety and effectiveness of insulin pups, pacemakers, hospital imaging machines and other electronic medical devices.

Sequana Medical NV has announced the US FDA approval of its Alfapump system for treating recurrent or refractory ascites due to liver cirrhosis. This approval marks Alfapump as the first active ...

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