FDA calls for healthcare worker feedback to enhance monitoring of AI-enabled medical devices in real-world settings.
Key Details
- 1FDA opens comment window (Sept 30–Dec 1) for real-world monitoring of AI-equipped devices.
- 2Agency seeks input on detection and mitigation of data/model drift and performance changes.
- 3Most current evaluations rely on static retrospective testing, which FDA says is insufficient.
- 4End-users with experience of deployed AI tools are specifically invited to contribute insights.
- 5Recent breakthroughs: FDA Breakthrough Device status for Aidoc's AI triage solution; new AI approaches to body composition assessment (Mass General Brigham), and mammogram-based CVD risk prediction.
Why It Matters
Robust post-market monitoring and ongoing user feedback are vital as more AI tools are deployed in radiology and medical imaging. These regulatory efforts shape safe, effective, and continually improving AI integration in clinical practice.
Source
AI in Healthcare
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