London-based has been issued a CE Mark Class lla certification in the United Kingdom and European Union for its AI-based technology that can diagnose chest X-rays as “normal.” According to the company, this is believed to be the world’s first such approval, and the algorithm’s high level of accuracy in identifying normal chest x-rays exams means that its “red dot platform” can be used to speed up the detection of 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.

On March 12, FDA cleared the use of’s red dot algorithm for “instant triage” in radiology. The clearance applies to the life-threatening condition of collapsed lung (pneumothorax) and alerts radiologists as soon as the X-ray image is captured.

“We are delighted to have received clearance for our algorithm in the United States. This is the result of significant time, resource and effort by the team to develop this technology to the point where we can quantifiably trust the AI and audit its decision-making process. Our highly-trained and experienced UK consultant radiologists have continually reviewed, annotated, and reported on patient images to help train the algorithm correctly. In the United States, three independent board-certified radiologists checked whether the results were correct against more than 800 cases from the UK and USA to validate the performance of the algorithm,” says Simon Rasalingham CEO. “FDA clearance is not just about safety but also about efficacy. We believe our technology can make a big difference to patient safety, the delivery of care and cost-savings to the system.”

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