Visiopharm, a world leader in AI-driven precision pathology software, today announced that its existing portfolio of diagnostic apps have all been certified under the new In Vitro Diagnostic Regulation (IVDR).
The major difference between the IVDD and the IVDR is the focus on performance evaluation and post market follow up. It’s not new that the safety, effectiveness as well as all product claims need to be substantiated with evidence. What is new, is the technical documentation review is focusing on whether the evidence is scientific and sound. As far as known, Visiopharm is the first digital pathology company to have their IVD devices certified under the IVDR.
Esther Abels, Chief Clinical and Regulatory Officer, Visiopharm said:
“This certification shows that we have our processes in place to ensure we deliver quality products to the clinical field. It is an important milestone in our continuous effort to support the pathology community to enhance capabilities in precision pathology with the goal to optimise patient care. In addition, this milestone is a stepping stone for our entry into the US market.”
Michael Grunkin, CEO, Visiopharm said:
“We have long had a strong strategic focus on AI-driven precision pathology supporting optimal treatment decisions based on companion-diagnostic tissue biomarkers. This includes development and deployment of integrated computational assays for standardisation through decision support and stain quality management. Regulatory approvals is a core-component of that strategy, and we are extremely proud to be the first digital pathology company, to the best of our knowledge, to announce that all our clinical apps are now certified under the new legislation. Our integrated computational assays are currently deployed on our diagnostic enterprise solution for fully digital pathology labs. Qualitopix will shortly introduce these apps on a novel diagnostic platform for partially digital pathology labs.”Visiopharm Categories: Press Releases