This episode examines FDA’s January sixth general wellness policy update clarifying wearable health technology regulation in response to enforcement actions, analyzes University of Michigan Law School proposals to shift medical AI oversight away from individual clinician review toward independent system evaluation, and covers new FDA clearances for IotaMotion’s robotic assisted cochlear implant system in pediatric patients and Pearl’s Second Opinion dental AI platform for panoramic radiograph analysis. The briefing concludes with joint FDA and EMA guiding principles establishing good AI practice standards for pharmaceutical development workflows across both regulatory jurisdictions.
