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FDA clears 'instant triage' radiology algorithm for pneumothorax – Med-Tech Innovation

 


The Food and Drug Administration (FDA) has authorized the use ofhere.aired dot algorithm for instant triage in radiology.

The authorization applies to the potentially fatal state of the collapsed lung (pneumothorax) and alerts radiologists as soon as the radiographic image is captured.

This announcement follows several other recent company highlights:

CEO Simon Rasalingham said: We are delighted to have received authorization for our algorithm in the United States. This is the result of the team's significant time, resources and efforts to develop this technology to the point where we can quantifiably trust AI and audit its decision-making process. Our highly qualified and experienced UK consultant radiologists have continuously reviewed, annotated and reported on patient images to help train the algorithm properly. In the United States, three independent, board-certified radiologists checked the results against more than 800 cases in the United Kingdom and the United States to validate the performance of the algorithm.

FDA clearance is not only a matter of safety but also of efficiency. We believe our technology can make a big difference to patient safety, caregiving and system cost savings. In the UK, our momentum continues with the deployment of the red dot solution in the NHS, providing an essential cost – an efficient and safe alternative to the way radiology departments can manage their workload.



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