HealthTech Horizons

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

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