Three Out of Thirteen Hundred: The Evidence Gap Inside FDA Cleared Medical AI - August 30, 2026

Three Out of Thirteen Hundred: The Evidence Gap Inside FDA Cleared Medical AI

A new census in PLOS Digital Health catalogued every AI and machine learning enabled medical device the Food and Drug Administration had cleared through December 2025, all 1,357 of them, and found that only three were ever evaluated against outcomes patients actually experience: mortality, morbidity, or readmission. Rick Spair and Laura trace the attrition from clearance to validation, the specialties where the gap runs widest, the Epic sepsis model and Watson for Oncology as cautionary tales, and what the agency's new generative AI device docket could change.

Hosted by Rick Spair and Laura.

The DX Today Podcast brings you daily deep dives into the most consequential stories in the AI ecosystem.

#MedicalAI #FDA #HealthTech #ClinicalValidation #AIRegulation