Diagnostics.ai has launched CE-IVDR Strategic Advantage Platform, a machine learning platform for clinical real-time polymerase chain reaction (PCR) diagnostics, aiming to provide transparency in molecular testing processes.
According to the company, this platform is the first to show how each diagnostic result is achieved, addressing the new EU regulations under the In Vitro Diagnostic Medical Devices Regulation (IVDR). The regulation requires stricter standards for diagnostic accuracy, reproducibility, and algorithm transparency, said Diagnostics.ai.
The CE-IVDR Strategic Advantage Platform is designed in response to these regulatory changes. It incorporates a “model-aware” architecture, allowing laboratories to understand artificial intelligence (AI)-generated recommendations.
Diagnostics.ai CEO Aron Cohen said: “While most diagnostic algorithms remain an impenetrable ‘black box,’ the PCR.AI API was engineered with transparency included from the ground up.
“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 features of the platform include transparent result attribution, which shows how results are obtained, and real-time model monitoring to track performance and detect drift, ensuring compliance with IVDR Article 72.
The platform also offers per-test algorithm accountability through straightforward reports that support comprehensive auditability. Clinician-ready explanations provide laboratory professionals and clinicians with clear interpretations of diagnostic outcomes, supporting informed clinical communication, said the firm.
Now available across Europe for clinical laboratories and diagnostic manufacturers, the platform includes the PCR.AI AI API registered under CE-IVDR and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), along with technical, regulatory, and implementation support to meet regulatory standards.
PCR.AI is already in use in the US, the UK, and other regions.
