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

https://pmc.ncbi.nlm.nih.gov/articles/PMC11638451/ By Alicia Toledano, ScD, President, Biostatistics Consulting A paper by Conant, Toledano, Periaswamy, et al., “ Improving Accuracy and Efficiency with Concurrent Use of Artificial Intelligence for Digital Breast Tomosynthesis ,” in Radiology: Artificial Intelligence, reports results of a reader study with 24 radiologists reading 260 Digital Breast Tomosynthesis (DBT) examinations (including 65 cancer cases). The paper was  re