Back to all news

FDA Seeks Real-World Performance Insights on AI Medical Devices

FDA Seeks Real-World Performance Insights on AI Medical Devices

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.
AI in Healthcare

Source

AI in Healthcare

View all from this source

Ready to Sharpen Your Edge?

Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.

We respect your privacy. Unsubscribe at any time.