News | Artificial Intelligence | April 15, 2020 gets CE Mark Approval for its AI-based chest X-ray diagnosis technology

Chest X-ray diagnosis to rule out normal exams using the Company’s technology could lead to an estimated £100m in cost savings to the NHS per year

#COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SARScov2

April 15, 2020 — has been issued with a CE Mark Class lla certification in the U..K and EU for its AI-based technology that can diagnose chest X-rays as ‘normal’. This is believed to be the world’s first such approval and has the potential to make up to £100m in cost savings for the U.K. NHS, the company estimates.

The algorithm’s high level of accuracy in identifying normal chest X-rays exams means that the red dot platform can be used to speed up the detection of those suspected with Covid-19. 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’s AI technology and to the design, development and manufacture of its red dot® platform.

“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,” said Simon Rasalingham, chairman and CEO of “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.”

“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,” said Thomas Naunton Morgan, M.D., chief medical officer of

The Company estimates that being able to ‘rule out normal’ could save the NHS over £100m per annum through a reduction in outsourcing costs.

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

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