Biomerica secures IVDR (In Vitro Diagnostic Regulation) certification, ensuring compliance with stringent European Union ...

Biomerica (BMRA) announces that its food intolerance products for Crohn’s Disease and Ulcerative Colitis have achieved CE-marking under the ...

The tests identify specific foods that may trigger inflammation in patients with Crohn's disease and ulcerative colitis.

Article 16 of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation specifically address the ...

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 ...

A new report by trade association MedTech Europe has revealed that the struggle for manufacturers to meet the requirements of the EU’s Medical Device (MDR) and In Vitro Diagnostics Regulation ...

AliveDx 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.

Ikeda's expertise includes FDA and EU submissions for the IVD industry, such as 510(k), premarket approval (PMA), PMA supplements, annual reports, and Class D IVDR dossiers.

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 ...