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regulatory

FDA
MedTech

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

The agency said the change aims to enable the use of more deidentified databases, including national registries, health systems and insurers.
Conor Hale 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
human brain abstract art

After 20 years, Medtronic claims neurostim approval in dystonia

Dec 4, 2025 10:25am

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