Most AI medical devices cleared for use were not tested on patient

Health technology can be useful, but it becomes risky when people mistake consumer sensors for medical devices. The key is understanding what the data actually shows and what it doesn’t.

Reporting

Phys.org Medical Research reports that Most AI medical devices cleared for use were not tested on patient outcomes. A new analysis shows that, of 1,357 artificial intelligence (AI)-based medical devices authorized by the U.S. Food and Drug Administration (FDA) for use in patient care, only three had been tested on whether they actually improve patients' health. The key issue is evidence: what the device measures, how reliable the measurement is, who can safely use it, and where medical guidance is still needed.

The Details

• Phys.org Medical Research: Most AI medical devices cleared for use were not tested on patient outcomes
• A new analysis shows that, of 1,357 artificial intelligence (AI)-based medical devices authorized by the U.S. Food and Drug Administration (FDA) for use in patient care, only three had

Next Developments

• peer review and replication of findings
• clinical applications and guidelines
• consult healthcare providers for personal advice

Medical Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always consult with qualified healthcare professionals for medical decisions and treatment options.