A health advisory committee recommended that Medicare consider measures such as time in range and safety data when making coverage decisions about diabetes devices. In a Tuesday meeting, the Medicare ...

Given the lack of information on their effectiveness and the unreasonable risks for illness or injury, spinal sphere devices should be regulated as Class 3 devices that require premarket approval (PMA ...

Ariel Seeley served on the panel titled AI Trends in Medical Devices: Global Developments, FDA Policies, and Software as a Medical Device at the 2025 Food and Drug Law Institute (FDLI) Annual ...

Why are we asking for donations? Why are we asking for donations? This site is free thanks to our community of supporters. Voluntary donations from readers like you keep our news accessible for ...

Medtronic suffered a regulatory and competitive setback Wednesday after a U.S. Food and Drug Administration advisory panel expressed concerns about Symplicity Spyral, a device to treat hypertension.

Please provide your email address to receive an email when new articles are posted on . An FDA panel voted that the benefits of a transcatheter edge-to-edge repair device outweigh risks in severe ...

Please provide your email address to receive an email when new articles are posted on . An FDA panel voted that for adults with uncontrolled hypertension, the benefits of a radiofrequency renal ...