Revvity said on Monday it has received a CE-IVD mark for a molecular testing platform that can be used to screen newborns for spinal muscular atrophy and severe combined immunodeficiency.

Roche announced on Monday that its hepatitis B immunoassay has received CE marking and is available for use in countries accepting the regulatory designation.

Roche announced on Thursday it received CE marking for two serology tests for hepatitis E.

Sansure Biotech has achieved a milestone in the field of immunodiagnostics, marking significant progress in international strategic expansion. On the evening of November 14, Sansure Biotech announced that its automated chemiluminescence immunoassay (CLIA) systems recently received the EU CE IVDR certification.

BioMérieux announced on Friday that it has obtained CE marking for an assay to detect two biomarkers associated with mild traumatic brain injury (mTBI).

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

Recently, Autobio's hepatitis B virus surface antigen (HBsAg) detection kit (magnetic particle chemiluminescence method) successfully passed the European clinical assessment and obtained the first EU CE IVDR Class D certification in China.

Medtronic has received a CE mark for its continuous glucose monitoring (CGM) device, Simplera, allowing the device to be marketed in the European Union.

Geneseeq Technology Inc. has announced that three of our next-generation sequencing (NGS)-based cancer genetic testing kits, GENESEEQPRIME NGS Tumor Gene Detection Kit (GeneseeqPrime ™), GENESEEQ Homologous Recombination Deficiency Detection Kit (GeneseeqPrime™ HRD), and GENESEEQ Blood Cancer Gene Detection Kit (Hemasalus™ DNA/Hemarna™ RNA), have obtained the European Union’s CE Mark approval.

Recently, Ustar and Hangzhou Biotest Biotech received the IVDR CE certificate from TÜV SÜD, a notified body designated under the EU's IVDR.