Today’s briefing covers FDA clearance of Qure.ai’s qXR chest x-ray detection platform trained on five million global images, institutional responses to the HHS request for information on clinical AI adoption barriers including submissions from ASCO and the Community Oncology Alliance, new FDA guidance establishing a Plausible Mechanism Framework for ultra-rare genetic therapies, regulatory approvals for Siemens’ second-generation Biograph One PET/MR and photon-counting CT systems in Canada, GE HealthCare’s MIM LesionID Pro tumor burden analysis clearance and SIGNA MRI portfolio additions, and the American College of Radiology’s petition to exempt radiologist-assist AI devices from 510(k) premarket notification requirements.
