Of more than 1,300 AI medical devices cleared by the FDA, only three tested for patient-centered outcomes like death and morbidity, data show.
AI integration into healthcare is rapidly progressing. Medical societies like the AMA have called for stricter regulations due to concerns about bias and transparency in clinics and health insurance decision-making.
According to Rawan Abulibdeh, a postdoctoral fellow at University Health Network in Canada, and colleagues, the FDA has cleared at least 1,357 AI medical devices.
“Clinical decisions increasingly depend on algorithmic outputs,” they wrote in