Skip to Main Content
Contribute Try STAT+ Today

The Food and Drug Administration has cleared scores of AI tools for use in the clinic, but there remains little publicly available data on how well those tools work on different groups of patients, a STAT investigation has found.

Of 161 AI products cleared by the FDA in recent years, only 73 disclosed the amount of patient data used to validate the performance of their devices in public documents. Only seven reported the racial makeup of their study populations, and just 13 provided a gender breakdown.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!


What is it?

STAT+ is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • STAT+ Conversations
  • Weekly opportunities to engage with our reporters and leading industry experts in live video conversations
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.