NEW YORK – Digital pathology firm Proscia announced on Wednesday that its Concentriq Dx platform has received CE mark under Europe's new In Vitro Diagnostic Regulation (IVDR) rules.
The new certification indicates that the software complies with stronger quality and safety standards than the traditional CE mark, which the company originally received in 2019, it said in a statement. The artificial intelligence-based software allows for remote reviewing and reporting of whole-slide images and can be integrated with laboratory information systems.
The IVDR certification "will enable the company's continued growth in the European diagnostic pathology market, where it is helping leading laboratories to modernize their routine operations," the firm added. The Philadelphia-based company has established subsidiaries in Ireland and Spain to drive international growth and help the firm "increasingly scale its operations and continue to support its expanding customer base."
Europe's new IVDR requirements to replace the original IVD Directive went into effect on May 26, although the date of application for devices that previously received CE-IVD marking has been extended through at least 2026.