UK’s Kheiron gets CE-Mark for breast cancer screening software

UK-based start-up Kheiron Medical Technologies has obtained the European CE-Mark for its new artificial intelligence (AI)-based breast cancer screening software as a second reader of mammographic images.

The software leverages deep learning that uses artificial neural networks and performance computing to precisely analyse complex medical images.

Kheiron said that the algorithm will facilitate efficient and accurate breast cancer detection at early stages. It is also expected to decrease the unnecessary invasive biopsies and radiation.

The company expects the breast cancer screening software to be launched on the country’s National Health Service (NHS) and European healthcare systems.

The tool is anticipated to reduce the screening workload of clinical staff in all types of settings, and offer a new option for the NHS to cater to the ongoing radiology workforce shortage.

Kheiron Medical Technologies chief medical officer Christopher Austin said: “With UK radiology workforce shortages in the spotlight, regulatory approval could actually position the UK and Europe as the world’s earliest adopters of AI at scale.

“European national breast screening programmes can now take the lead and demonstrate how to leverage high quality, proven, and safe machine learning technologies to run screening programmes better, smarter and more cost-effectively for millions of women.”

In an independent multi-centre clinical study, the new breast cancer screening software demonstrated better accuracy compared to single radiologist reporting.

The company is additionally conducting multi-phase clinical evaluations across the UK, Europe and the US to further evaluate and improve the performance of the AI-based software.