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CEST Biocartis Announces IVDR Class C CDx Certification of the Idylla™ EGFR Mutation Test Mechelen, Belgium, 02 June 2025 – ...
With early detection of prostate cancer recognised as a critical part in reducing the disease’s mortality rate, PanGIA ...
and Class B and A Sterile devices). As of today, there are in fact only 12 appointed Notified Bodies for IVDs in Europe, so, ensuring that one takes on a new device is not an easy feat.
Japan approves ILMN's TSO Comprehensive, marking a key step forward in global precision oncology adoption and clinical use.
Illumina Inc. ILMN recently introduced PromoterAI, a new AI algorithm that accurately deciphers pathogenic regulatory genetic variants in the noncoding regions of the human genome. PromoterAI turns ...
A certificate of compliance with the IVDR will be required for most IVD device to be sold in the EU. Devices are classified according to their risk to public and personal health. Class D devices, with ...
Orchestra BioMed holds two best-in-class medical device therapies targeting large markets. Find out why OBIO stock is a Buy.
DUBLIN--(BUSINESS WIRE)--The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation ... transition to the new IVD/Medical Device Regulations ...