NEW YORK – Molecular Health said Wednesday that its MH Guide clinical decision support software has received certification under the European Union's new In Vitro Diagnostics Regulation (IVDR).
The German bioinformatics firm, based in Heidelberg, said that MH Guide is the first clinical decision support product to earn such certification under the regulation, which took effect in May.
MH Guide, previously registered as an IVD device in the EU, is designed to help molecular pathology laboratories clinically interpret genetic tumor profiles.
"When it comes to understanding serious diseases and supporting molecular pathologists in their clinical reporting, there can be no compromise on quality. This has been and remains our highest priority for our products and development services," Molecular Health CEO Friedrich von Bohlen said in a statement. "We are certain that these regulations will gain importance against the backdrop of much needed digitalization in healthcare systems."