Comprehensive guide to DTx reimbursement in France. Learn how digital therapeutics (DTx) navigate CNEDiMTS evaluation, PECAN requirements, and scientific methodology standards for HAS approval. The Urgency of Securing HAS Approval …

The European framework for digital health technology assessment represents a watershed moment for innovation companies seeking reimbursement across fragmented national systems[1][5]. Rather than navigating each country’s unique evaluation pathway from …

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 …