Diagnostics.ai Introduces Industry’s First Transparent Machine Learning Platform for Real-Time PCR Diagnostics in Line with CE-IVDR Regulations
As the CE-IVDR compliance deadline of May 26 takes effect, Diagnostics.ai has unveiled a groundbreaking, fully-transparent machine learning platform tailored for clinical real-time PCR diagnostics. This marks a milestone in molecular testing, being the first solution to offer full visibility into how every diagnostic result is derived — a major leap from traditional black-box models.
Backed by over 15 years of deep expertise and millions of test results processed with over 99.9% accuracy, this innovation stands as a trusted and proven solution in the field of molecular diagnostics.
Strategic Compliance for CE-IVDR: A Transparent Edge
In response to the increasing rigor of the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR), the company has launched its CE-IVDR Strategic Advantage Platform. Designed to align with stricter demands on diagnostic precision, repeatability, and transparency in AI algorithms, this platform provides laboratories with a reliable and compliant path forward.
“Most diagnostic systems today still operate as ‘black boxes’—offering little insight into how conclusions are reached,” said Aron Cohen, CEO of Diagnostics.ai. “With PCR.AI, we’ve built transparency directly into the architecture. Our system meets the highest regulatory standards and allows full traceability of AI-driven decisions.”
Revolutionary Features of the PCR.AI Transparent AI Platform
1. Transparent Attribution of Results
Enables labs to see exactly how a diagnosis was made—without relying on after-the-fact interpretations.
2. Real-Time Model Supervision
Provides continuous monitoring of model performance, helping labs fulfill Article 72 of IVDR by detecting any performance drift immediately.
3. Test-Level Algorithm Accountability
Offers per-test reports that are easy to understand, simplifying audits and regulatory reviews.
4. Clinician-Ready Explanation Engine
Supports lab technicians and clinicians with detailed, easy-to-interpret explanations that enhance communication and patient trust.
“Our solution delivers both regulatory confidence and clinical transparency,” said Dr. Brian Glenville, MD, Chairman of Diagnostics.ai. “Now, lab directors can show exactly how a result was derived—not just to auditors, but to clinicians and even patients—instilling a new standard of trust in diagnostics.”
Now Available Across Europe
The PCR.AI CE-IVDR Strategic Advantage Platform, which includes the CE-IVDR and MHRA-compliant PCR.AI API as well as comprehensive regulatory, technical, and onboarding support, is now widely available to clinical labs and diagnostic manufacturers across Europe.
Already successfully deployed in the U.S., U.K., and other regions, PCR.AI is trusted by leading laboratories for its exceptional accuracy and unmatched transparency.
