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 ...

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 ...

A 15-person FDA Circulatory System Devices Panel has unanimously voted against Johnson & Johnson MedTech’s V-Wave Ventura interatrial shunt, creating a setback for the major medtech leader. The panel ...

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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 ...

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.