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

A JAMA study of 903 FDA-authorized AI medical devices shows fewer than one-third have been tested on female patients, highlighting a regulatory gap where FDA approval does not require sex-specific validation. This exposes a systemic risk of bias in AI diagnostics trained primarily on male data without mandated clinical performance studies, raising ethical and efficacy concerns for healthcare innovation.

This Wire brief sits within Fusion42's coverage of Healthtech Infrastructure.