As the CE-IVDR compliance period is introduced, diagnostics. The technology is supported by over 15 years of experience and millions of successfully processed samples with> 99.9% of proven accuracy.
The CE-IVDR strategic platform is diagnostics. AA response to a new wave of strict EU regulations as part of the diagnostic regulation of in vitro medical devices (IVDR), which require increased diagnostic accuracy, playback and transparency of the algorithm.
said Aron Cohen, CEO Diagnostics.Ai
Key innovations of transparent AI architecture
The PCR.Ai platform is built around the pioneering “model” of architecture, enabling laboratories to understand the suggestions that AI presents.
Illuminated benefits:
- Transparent assignment of results It directly shows how and why the result was achieved, eliminating the interpretations of post-hoc.
- Model monitoring in real time It enables laboratories to track the model performance and detection of a drift in real time – meeting the requirements of IVDR Article 72.
- The algorithm responsibility for the test Easy to understand test reports, ensuring comprehensive control ability.
- Generating explanations ready for the clinician It provides bright laboratory specialists and clinicists, controlled explanations of diagnostic results, supporting conscious clinical communication.
said Dr. Brian Glenville MD, chairman of diagnostics.
Now available throughout Europe
PCR.AI CEI -IVDR Strategic Advantage platform – including registered by CE -IVDR and MHRA API PCR.AI AI, as well as technical, regulatory and implementation support – is now available in Europe for both clinical laboratories and diagnostic producers, authorizing them to meet and exceed achievement of deep trust.
Already in successful use in the USA, Great Britain and other countries, PCR.AI is trusted by leading laboratories for reliable and transparent diagnostic results.