Diagnostics.ai Launches Industry's First CE-IVDR Certified Transparent AI Platform for Molecular Diagnostics as Regulatory Deadlines take Effect

CE-marked under the EU IVDR regulation, Diagnostics.ai's platform is the first to deliver algorithmic transparency and per-test auditability for clinical PCR diagnostics

Revolutionary Platform Sets New Benchmark for Transparency and Compliance in Diagnostic AI

As the May 26th CE-IVDR compliance deadline comes into effect, Diagnostics.ai launches the industry’s first fully-transparent machine learning platform for clinical real-time PCR diagnostics – demonstrating exactly how each result was achieved, a first for molecular-testing machine learning. The technology is backed by over 15 years of experience and millions of successfully processed samples with >99.9% proven accuracy.

The CE-IVDR Strategic Advantage Platform is Diagnostics.ai's response to the new wave of stringent EU regulations under the In Vitro Diagnostic Medical Devices Regulation (IVDR), which demand heightened standards for diagnostic accuracy, reproducibility, and algorithm transparency.

“While most diagnostic algorithms remain an impenetrable ‘black box,’ the PCR.AI API was engineered with transparency included from the ground up,” said Aron Cohen, Chief Executive Officer of Diagnostics.ai. “Our platform delivers transparency and traceability that meet and support the highest standards set by CE-IVDR, making the AI decision-making process visible, understandable, and traceable.”

Key Innovations of the Transparent AI Architecture

PCR.AI’s platform is built around a pioneering “model-aware” architecture, enabling laboratories to understand the suggestions that the AI makes.

Highlighted Benefits:

• Transparent Result Attribution Directly shows how and why a result was achieved, eliminating reliance on post-hoc interpretations.
• Real-Time Model Monitoring Allows laboratories to track model performance and detect drift in real time – meeting IVDR Article 72 requirements.
• Per-Test Algorithm Accountability Easy to understand per test reports, ensuring comprehensive auditability.
• Clinician-Ready Explanation Generation Provides laboratory professionals and clinicians with clear, auditable explanations of diagnostic outcomes, supporting informed clinical communication.

“Our platform bridges the gap between compliance necessity and clinical confidence,” said Dr. Brian Glenville MD, Chairman of Diagnostics.ai. “Laboratory directors can now explain to regulators, clinicians, and patients exactly how each diagnostic result was determined, creating a new level of trust in molecular diagnostics.”

Now Available Across Europe

The PCR.AI CE-IVDR Strategic Advantage Platform - including the CE-IVDR and MHRA registered PCR.AI AI API, as well as technical, regulatory and implementation support - is now available across Europe for both clinical laboratories and diagnostic manufacturers, empowering them to meet and exceed regulatory obligations while achieving deeper confidence in diagnostic results.

Already in successful use in the U.S., U.K., and other countries, PCR.AI is trusted by leading laboratories for its reliable and transparent diagnostic performance.

About Diagnostics.ai

Diagnostics.ai is an established leader in AI-powered PCR analysis with over 15 years of experience serving clinical laboratories worldwide. The company has processed millions of samples with documented >99.9% accuracy and maintains full CE-IVDR and MHRA compliance. PCR.AI's transparent machine learning platform transforms laboratory efficiency while enabling regulatory compliance.

Learn more at www.diagnostics.ai Email inquiries: info@diagnostics.ai

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