Why 95% of FDA-Cleared AI Fails to Help Patients

Logosofia no Dia a Dia · Mar 26, 2026 · 21m

As the FDA clears over 1,400 AI medical devices, a startling gap remains: 95% of these tools have no reported impact on patient health outcomes. This episode explores the "AI Chasm" and the technical pivot from isolated detection tools to workflow-native, multimodal systems like Pillar-0 and GigaTIME. We dive into the high-stakes battle between general-purpose models and specialized medical pipelines, the rise of indistinguishable deepfake X-rays, and the new methods being developed to ground AI predictions in physical reality. Join us as we examine how the medical field is moving beyond…