The Food and Drug Administration (FDA) has cleared the use of behold.ai’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.
This announcement follows a number of other recent highlights at the Company:
Chief executive Simon Rasalingham said: “We are delighted to have received clearance for our algorithm in the US. 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 USA, three independent board-certified radiologists checked whether the results were correct against more than 800 cases from the UK and the USA to validate the performance of the algorithm.
“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. In the UK, our momentum continues with the roll out of the red dot solution across the NHS, delivering an essential, cost-effective and safe alternative to the way radiology departments can manage their workload.”