Puraite aims to significantly shorten manual literature research in life sciences with explainable AI. About the startup's ...

The course offers opportunities to master US and EU regulatory frameworks for PCR-based diagnostics, focusing on FDA regulations, EU MDR/IVDR, and quality management systems. It enables effective ...

Almirall, S.A. (ALM), a global biopharmaceutical company dedicated to medical dermatology, have announced an expanded collaboration with the Barcelona Supercomputing Center ? Centro Nacional de ...

During Child Abuse Prevention Month 2026, Darkness to Light is launching a national campaign focused on how to prevent child sexual abuse and protect children before harm occurs. The campaign, ...

In recent years, the in vitro diagnostics (IVD) regulatory landscape in Europe has changed and we are now in the transition from IVD Directive 98/79/EC (IVDD) to In Vitro Medical Devices Regulation ...

IdentiClone ® Dx IGH is the first IVDR-certified assay for the detection of clonal immunoglobulin gene rearrangements in patients with suspected B-cell lymphoproliferative disease. BSI (Netherlands), ...

Top European officials said they are optimistic that amendments to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) will be enacted quickly, but the amendments must also ...

Invivoscribe, a global leader in precision diagnostics and measurable residual disease (MRD) testing, is proud to announce that its IdentiClone Dx IGH Assay has received In Vitro Diagnostic Regulation ...

IdentiClone ® Dx IGH is the first IVDR-certified assay for the detection of clonal immunoglobulin gene rearrangements in patients with suspected B-cell lymphoproliferative disease. SAN ...

IdentiClone® Dx IGH is the first IVDR-certified assay for the detection of clonal immunoglobulin gene rearrangements in patients with suspected B-cell lymphoproliferative disease. Invivoscribe, a ...

Early diagnosis through the use of in vitro diagnostics (IVDs) plays a critical role in patient outcomes and in supporting the healthcare system as a whole. IVDs are defined in the new EU IVDR ...

An overview of technical documentation, transition, PMS, and clinical evidence for companies facing the Notified Body process ...