AI in Medicine News ・ ⚖️ Device approvals and regulation

One-Third of 163 FDA-Cleared AI Medical Devices Got Algorithm Updates, but Most Reported No Clinical Benefit Data

Medical Daily · 11/08 01:01 UTC

A study of 163 FDA-cleared AI medical devices found that one-third received algorithm updates. Of the updated devices, 85.7% reported no clinical or organizational benefit data.

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