A new study finds fewer than 30% of FDA-cleared AI medical devices reported key safety or adverse event data before approval.
Key Details
- 1Study reviewed FDA data for AI/ML devices cleared between 1995 and July 2023.
- 2Out of 691 devices analyzed, 531 were radiology-specific.
- 3Fewer than 30% of devices shared safety or adverse event information prior to clearance.
- 4Authors call for more stringent testing and clearer regulatory standards.
- 5Lack of predefined efficacy and risk standards highlighted as a critical issue.
Why It Matters
Radiology relies heavily on AI devices, making their safety and efficacy crucial to patient care. The study urges tighter oversight and transparency, which could directly impact how radiologists incorporate AI into practice.
Source
Health Imaging
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