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

HealthTech Horizons By Shannon Campbell, PhD, Principal Consultant, Frank Healthcare Advisors As we close out 2025, a year of rapid transformation, investor recalibration, and regulatory evolution, it’s worth stepping back and assessing where MedTech, and in particular AI-enabled Software as a Medical Device (AI-SaMD), truly stands.   1) Funding: Healthy Growth — But Uneven On the funding front, the narrative for MedTech in 2025 is nuanced rather than dramatic: ·       Total