IVDR Archives - PharmaDeviceNews

What Invivoscribe’s IdentiClone Dx IGH approval reveals about the new economics of IVDR-ready hematology diagnostics

By Pallavi Madhiraju on March 26, 2026 Medical Devices & Diagnostics

Invivoscribe’s IdentiClone Dx IGH won IVDR certification in the EU. Read what this means for clonality testing, lab adoption, and diagnostic competition.

Guardant and Gemelli bring precision oncology in-house: What it means for EU care delivery

By Venkatesh B on December 9, 2025 Medical Devices & Diagnostics

Guardant Health brings its Guardant360 CDx test to Policlinico Gemelli in Italy. Find out how in-house liquid biopsy could reshape cancer diagnostics in Europe.