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By Richard Frank, MD, PhD, Founder and Principal Consultant, Frank Healthcare Advisors November 28th 2025 AI-enabled medical devices, once seen as futuristic, are now routinely cleared by FDA to detect retinal disease, analyze cardiovascular physiology, classify imaging features, and autonomously interpret clinical signals. Yet despite rapid technological progress, commercial adoption for many AI solutions remains difficult. Innovators often underestimate one of the biggest b

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

By Luca Bogoni, PhD, Founder & Principal, HealthTech Strategies December 8th, 2025 RSNA 2025 highlighted that while modality-level innovation remains central to radiology’s progress, a complementary set of changes is emerging in how image intelligence—augmented by patient context, risk information, and clinical guidelines—is interpreted, documented, and integrated across enterprise systems . Multimodal AI, automated reporting, integrated solution portfolios, distributed ecosy

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

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

By Shannon Campbell, PhD, Principal Consultant, Frank Healthcare Advisors In December 2025, the FDA announced agency-wide deployment of agentic AI, advanced systems capable of planning and executing multi-step tasks to support regulatory, scientific, and administrative workflows. While human oversight remains mandatory, these tools are expected to accelerate coordination, improve consistency, and strengthen analytical review  across the Agency. For developers of AI-enabled di

By Shannon Campbell, PhD, Principal Consultant, Frank Healthcare Advisors November 28, 2025 The Digital Medicine Society (DiMe) has released “ The Playbook: Implementing AI in Healthcare ” , a comprehensive, practice-oriented guide designed to help healthcare organizations adopt and scale artificial intelligence responsibly. While the Playbook is positioned primarily for health systems and digital transformation leaders, its implications for manufacturers developing AI-enable

By Shannon Campbell, PhD, Principal Consultant, Frank Healthcare Advisors November 28, 2025 Artificial intelligence (AI) is transforming diagnostics, imaging analysis, and clinical decision-making across the healthcare ecosystem. However, translating promising algorithms into regulated, clinically adopted Software as a Medical Device (SaMD) is a complex, multidisciplinary challenge. Success requires far more than algorithmic performance: it demands systematic alignment of reg

By Alicia Toledano, ScD, President, Biostatistics Consulting November 28, 2025 What sample size do I need? Sample size impacts budget, feasibility, and success of regulatory applications for in vitro  diagnostic tests (IVDs). At least as important is having an unbiased study – at minimum, the study sample should represent the intended use population and the “ground truth” against which performance of the IVD will be measured must be trustworthy. Once those are set up, sample

By Luca Bogoni, PhD, Founder & Principal, HealthTech Strategies November 28, 2025 In early 2025 the FDA released a new draft guidance designed to help developers build safer, more transparent, and more reliable AI-enabled medical devices  FDA Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices . As AI continues to transform imaging, diagnostics, monitoring, and clinical decision support, the agency is aiming to ensure that innovation is supported