Proscia’s Concentriq Dx Gets CE-IVDR Mark for Use in Primary Diagnosis

Philadelphia, Pa.-based Proscia’s Concentriq Dx image analysis software has gained a CE-IVDR mark certifying its conformance with the EU’s In Vitro Diagnostic Regulation (IVDR) for use in primary diagnosis.

The digital platform, which is used in clinical laboratories for pathology diagnosis, is also available for primary diagnosis in the U.S. during the COVID-19 public health emergency, the company said.

In addition, the platform offers a microscope-like viewing experience in a digital pathology environment.

Proscia said the CE-IVDR mark will enable the company’s continued growth in the European diagnostic pathology market.