Resources: MedTech, CDx, IVDR/MDR Insights

FDA’s New CDx Pathway vs EU IVDR: Harmonised Science, Diverging Workload

27.11.2025

IVD News | Precision Medicine & CDx

FDA Proposes to Down‑Classify Key Oncology Companion Diagnostics to Class II: What CDx Sponsors Need to Know

27.11.2025

IVD News, Regulatory Updates | Precision Medicine & CDx

Spanish IVD Regulation 2025 – New Royal Decree Updates for IVD Manufacturers, Sponsors, and Labs

21.10.2025

Blog & Insights, IVD News | Digital Health & AI, IVDs, Laboratories, Precision Medicine & CDx

TGA guidance (Oct 2025): IVD Companion Diagnostics (CDx) Requirements in Australia

16.10.2025

Blog & Insights, IVD News | IVDs, Precision Medicine & CDx

IVDR CE marking NGS: MDx Case Study with Fulgent

07.10.2025

Blog & Insights, Case studies, IVD News | Digital Health & AI, IVDs, Laboratories, Precision Medicine & CDx

MDx CRO co-authors Journal of Liquid Biopsy paper on EU–US collaboration for IVDR-ready liquid biopsy validation

21.08.2025

Blog & Insights, IVD News | IVDs, Precision Medicine & CDx

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