regulatory

heart model with cardiologist
MedTech

Edwards nets FDA approval for Sapien M3 mitral valve replacement

The approval marks the first for a type of implant that takes a safer route through the heart’s chambers, Edwards said.
Conor Hale Dec 23, 2025 11:00am
FDA

FDA opens door to more real-world datasets in device submissions

Dec 16, 2025 10:50am
human brain abstract art

FDA clears Medivis AR headset platform for neurosurgery

Dec 16, 2025 9:00am
HeartBeam

HeartBeam swells on turning FDA rejection into ECG clearance

Dec 11, 2025 11:50am
Flow Neuroscience

FDA approves 1st nondrug, at-home treatment for depression

Dec 11, 2025 6:00am
Francis Medical Vanquish water vapor ablation

FDA clears Francis Medical's water vapor prostate tumor ablation

Dec 10, 2025 9:25am