The company has received certification under Europe's In Vitro Diagnostic Regulation for a number of tests recently.

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 ...

MRC Holland recently announced that five SALSA MLPA assays for the detection of hereditary breast and ovarian cancer (HBOC) ...

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 ...

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.

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