FDA's AI Device Rules Let Healthcare Diagnostics Skip Female Validation

A JAMA Network Open analysis of 903 FDA-approved AI medical devices found fewer than a third include performance data by sex. MIT researchers found the models recommend less intensive treatment for women than men with identical symptoms.

• 903 FDA-approved AI medical devices analyzed
• Fewer than a third provide efficacy data by sex
• MIT AI models assign women less intensive care
• Gender bias embedded in approved diagnostic tools