The new In Vitro Diagnostic Regulation (IVDR) has been defined as one of the most significant changes in the EU legislation for In Vitro Diagnostics in the past 20 years. Due to the nature of the ...

IVDR: where are we now in molecular testing? How IVDR implementation is progressing in molecular biology laboratories in different European countries IVDR, the new EU legislation for in-vitro ...

BOSTON--(BUSINESS WIRE)--Ibex Medical Analytics (Ibex), a leader in artificial intelligence (AI)-powered cancer diagnostics, today announced it has received In Vitro Diagnostic Medical Devices ...

Certification for two in-vitro diagnostic (IVD) products - the CupiKIT HIV 1&2 Antibody Test Kit and the CupiKIT Hepatitis B Surface Antigen (HBsAg) Test Kit.

The European Commission’s (EC) delays to the implementation of the in vitro diagnostic regulation (IVDR) are creating a drag on IVD innovation in Europe, a regulatory expert has said. Introduced in ...

BOSTON and ROLLE, Switzerland, Aug. 14, 2024 /PRNewswire/ -- SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and a global leader in data-driven medicine, today announced ...

SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (NYSE: A) today announced that previously CE-IVD marked instruments, kits, and reagents were released as IVDR Class A on May 26, 2022, ...

Mechelen, Belgium, 02 June 2025 – Biocartis NV (“Biocartis”), an innovative molecular diagnostics company, is pleased to announce that its Idylla™ EGFR Mutation Test has received the European Union ...