Why 68% of Diagnostic AI Companies Leave 3-5x Valuation on the Table. How to Compress AI Diagnostic Procurement From 12 Months to 4 Months. AI Diagnostic Revenue Gap: Why Evidence …

Norway’s FlowOx Approval 2026: Complete Health Technology Assessment & Procurement Guide. The Brilliance of Iacob Mathieson. Discover how Norway approved FlowOx for peripheral arterial disease. Explore the evidence, HTA framework, …

The Approval Illusion: When Regulatory Success Masks Commercial Collapse It all began with the reimbursement of Casgevy (exagamglogene autotemcel), which received FDA breakthrough therapy designation in 2023 and full approval …

EU MDR Classification for Digital Health Software: Why “Not Intended for Medical Use” Fails and How Regulatory Debt Emerges “Not Intended for Medical Use” Executive Summary A persistent and dangerous …

In September 2024, the Australian Government published the final report of the Health Technology Assessment (HTA) Policy and Methods Review. On the surface, it is a national reform document. In …

Governing the next generation of clinical intelligence Artificial intelligence is rapidly moving from research laboratories into everyday clinical practice. Algorithms now assist clinicians in interpreting radiological images, predicting patient deterioration, …