AI-based tech for chest X-ray diagnosis receives CE Mark

behold.ai has been issued with a CE Mark Class lla certification in the UK and EU for its AI-based technology that can diagnose chest X-rays as ‘normal’.

The company claims it has the potential to make up to £100 million a year in cost savings for the NHS.

Simon Rasalingham, chairman and CEO of behold.ai, said: “This is a great result for the company and for our team of quality leaders, AI engineers and clinicians who have worked for years to develop a system that meets the highest quality standards. There is, quite rightly, a big focus on ensuring that the relatively new technology of artificial intelligence produces solutions that have a high degree of accuracy, reliability and scalability. This first in-kind regulatory approval is a key achievement for companies in this sector, the first autonomous AI algorithm to rule out normal chest X-rays.”

behold.ai and Wellbeing Software recently announced a collaboration to fast-track the diagnosis of COVID-19 in NHS hospitals using artificial intelligence analysis of chest X-rays. A national roll-out would enable a large number of hospitals to triage suspected COVID-19 patients inside and outside of the hospital setting using chest X-rays. This is currently being used as the key diagnostic test for triage of COVID-19 patients. This solution is also useful in dealing with the backlog of radiology cases, such as suspected lung cancer patients.

The CE Mark approval, issued to the company by the British Standards Institute, relates to the full quality assurance system for behold.ai’s AI technology and to the design, development and manufacture of its red dot platform.

Dr Thomas Naunton Morgan, chief medical officer of behold.ai, said: “Crucially, at a time when NHS radiologists are increasingly reporting images from home, our technology is fast, safe and effective both inside and outside the hospital setting. For examinations identified by our algorithm as normal, with a high degree of confidence, our results can be automatically accepted as being as accurate as an experienced consultant radiologist, and much faster.”

Earlier this year, behold.ai received FDA clearance for its red dot algorithm ‘instant triage’ system in relation to the life-threatening condition of pneumothorax.