Odelle Technology

In the rapidly evolving realm of digital health, ensuring that innovative technologies are both safe and effective is paramount. For digital health manufacturers, understanding and navigating the assessment frameworks that …

As we mark Breast Cancer Awareness Month, it’s vital to highlight the progress being made in the tools we use to diagnose and treat this complex disease. Among the latest innovations …

In Spain, getting in vitro diagnostics (IVDs) reimbursed involves navigating distinct pathways, each with its focus and requirements. The three primary systems are theSpanish Catalogue of Health Products, the Common …

GSK is taking a bold step forward in the fight against immune-related diseases by investing £50 million into a new five-year collaboration with the University of Cambridge and Cambridge University Hospitals. Dubbed the Cambridge-GSK Translational …

Roche Diagnostics has reached a major milestone as the World Health Organisation (WHO) has granted pre-qualification to its cobas® HPV test for use on the cobas 5800, 6800, and 8800 systems, including for …

The structure of roles and responsibilities under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) brings together a blend of EU-level regulation and local oversight. This balance ensures that while …

The NHS Work Programme plays a vital role in ensuring patients across the UK gain access to innovative and effective treatments. Through a rigorous evaluation process, the Clinical Priorities Advisory …

Regulatory Pathway for Companion Diagnostics in France In France, companion diagnostics (CDx) are subject to a thorough regulatory and reimbursement process, primarily led by the Haute Autorité de Santé (HAS). …

Companion diagnostic (CDx) is evaluated and listed in the EBM (Einheitlicher Bewertungsmaßstab) catalogue in Germany, let’s enrich the discussion around each step, focusing on specific mechanisms, scientific rationale, and real-world examples. Here’s a …

The French healthcare system is well-regarded for its extensive coverage and robust framework for evaluating and reimbursing medical devices. At the heart of this system is the Liste des Produits …