The FHA Knowledge Hub By Shannon Campbell, PhD, Principal Consultant, Frank Healthcare Advisors On December 5, 2025 , the U.S. Food and Drug Administration (FDA) unveiled a groundbreaking initiative, the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot,  aimed at expanding patient access to digital health technologies that can transform chronic disease management. This first-of-its-kind pilot, developed by the FDA’s Center for Devices an

By Luca Bogoni, PhD, Founder & Principal, HealthTech Strategies At RSNA 2025, a quiet but powerful shift in diagnostic imaging took shape: ultra-portable X-ray systems are advancing beyond traditional mobile carts to lightweight, point-of-care platforms capable of expanding access to radiography across community clinics, home care, and remote settings. From handheld carbon-nanotube emitters to compact kits and foldable cart systems, this emerging ecosystem is redefining where