Diagnostics.ai Launches CE-IVDR Certified AI Platform for Molecular Diagnostics

Diagnostics.ai has launched the industry's first CE-IVDR certified transparent AI platform for molecular diagnostics, as announced in a press release. This platform is designed to meet the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR) standards, which emphasize diagnostic accuracy, reproducibility, and algorithm transparency.

The platform, known as PCR.AI, provides algorithmic transparency and per-test auditability for clinical PCR diagnostics. It allows laboratories to understand how AI-generated PCR result analyses are achieved, a significant advancement in molecular-testing machine learning. The technology is backed by over 15 years of experience and has processed millions of samples with over 99.9% accuracy.

Key features of the platform include real-time model monitoring, per-test algorithm accountability, and clinician-ready explanation generation. These features ensure comprehensive auditability and support informed clinical communication, bridging the gap between compliance necessity and clinical confidence.

The PCR.AI platform is now available across Europe, empowering clinical laboratories and diagnostic manufacturers to meet regulatory obligations while enhancing confidence in diagnostic results. It is already in successful use in the U.S., U.K., and other countries, trusted for its reliable and transparent diagnostic performance.