As the May 26 CE-IVDR compliance deadline comes into force, Diagnostics.ai launches the first fully transparent mechanical learning platform of the industry for real-time clinical PCR diagnostics by showing how each outcome was achieved, a first for the Molecular Machine. Technology is supported by over 15 years of experience and millions of successfully elaborated samples with proven accuracy> 99.9%.
The CE-IVDR strategic advantage is the response of Diagnostics.Ai to the new wave of strict EU regulations under the In vitro diagnostic medical devices (IVDR), which require increased standards for diagnostic accuracy, reproduction and transparency of algorithm.
“While most diagnostic algorithms remain an impenetrable ‘black box’, API PCR.AI was designed with transparency from the ground.” said Aron Cohen, chief executive of Diagnostics.ai. “Our platform offers transparency and traceability that meet and support the highest standards set by CE-IVDR, making the AI ​​decision-making process visible, understandable and detectable.”
Basic innovations of transparent AI architecture
The PCR.AI platform is built around an innovative “model” architecture, allowing the laboratories to understand the AI ​​proposals.
Highlighted benefits:
- Transparent results It immediately shows how and why it was achieved, eliminating the dependence on post-HOC interpretations.
- Model monitoring in real time It allows laboratories to monitor the performance of the model and detect Drift in real time – meeting IVDR Article 72 requirements.
- Algorithm accounting per test Easy understanding per test reports, ensuring comprehensive audit capability.
- Generation of explanations ready for a clinical doctor It provides laboratory professionals and clinicians with clear, controlled explanations of diagnostic results, supporting up -to -date clinical communication.
“Our platform bridges the gap between the necessity of compliance and clinical confidence.” said Dr. Brian Glenville MD, president of Diagnostics.ai. “Laboratory managers can now explain to regulators, clinical doctors and patients in the way any diagnostic effect has been determined, creating a new level of confidence in molecular diagnostics.”
Now available throughout Europe
The PCR.AI CE -IVDR strategic advantage – including CE -IVDR and MHRA posted PCR.AI AI API, as well as technical, regulatory and implementation – is now available throughout Europe for both clinical laboratories and diagnostic manufacturers, regulatory obligations, while achieving deeper confidence in the results of the diagnosis.
Already in successful use in the US, the United Kingdom and other countries, PCR.AI trusts the top laboratories for reliable and transparent diagnostic performance.
