An industry source said “most, if not all” of the people at CDRH who were recently dismissed are now being asked to return.

The BrainSense Adaptive technology is an enhancement to Medtronic’s Percept DBS neurostimulators. The advancement personalizes therapy based on a patient’s brain activity in real-time. Therapy ...

Interim CEO Brent Shafer said the medical products maker is ready to begin a new era after several years of “heavy lifting” ...

Expanding parts inventory and logistics capabilities will support later cutoff times, same-day delivery within 300 miles and ...

The cuts at the FDA’s device center could add “months, if not years” to the time it takes to bring products to market, an ...

FTC Chair Andrew Ferguson sent a memo to agency staff on Tuesday clarifying that the Biden-era guidelines will remain in ...

Philips forecast a double-digit sales decline in China for the first half of 2025 after reporting “significant deterioration” ...

Scott Whitaker sent a letter to the HHS calling for staff cuts at the FDA to be reversed, arguing patient care and U.S.