What It Is, How It Works, and What Success Actually Requires Introduction: The Hidden Architecture of French Reimbursement In France, a single institution holds the power to determine whether a …
Yearly Archives
2026
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DiappyMed and Sanofi Partnership: Transforming Digital Diabetes Care in France DiappyMed’s €5 million seed funding round and strategic partnership with pharmaceutical giant Sanofi represent a pivotal moment for digital therapeutics …
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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 …
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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 …
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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 …
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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, …
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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 …
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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 …
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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 …
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News
The EU Artificial Intelligence Act: Why Understanding Europe’s New Framework for Medical AI is important
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, …