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regulatory
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
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HeartBeam swells on turning FDA rejection into ECG clearance
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FDA approves 1st nondrug, at-home treatment for depression
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