Biomerica, EU and IVDR
After several high-profile scandals surrounding medical devices, where irresponsible manufacturers’ malpractice in cutting corners showed how easy it was to abuse the Directive, the IVDR came ...
Article 16 of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation specifically address the ...
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AliveDx gains IVDR CE mark for MosaiQ AiPlex CTDplus assayAliveDx has obtained a CE mark under the EU's in vitro diagnostic regulation (IVDR) for the AiPlex connective tissue disease (CTDplus) multiplex assay for use with its MosaiQ planar microarray ...
MRC Holland recently announced that five SALSA MLPA assays for the detection of hereditary breast and ovarian cancer (HBOC) ...
The Amsterdam-based company recently received IVDR certification for other tests including one for phenylketonuria.
Aiforia® Prostate Cancer Gleason 4 Cribriform and Perineural Invasion (PNI) AI models assist pathologists in detecting these patterns in whole slide images (WSI) of prostate tissue. These AI models ...
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