The US 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.
‘Instant triage’ offers clear benefits over conventional human-read processes when time is of the essence; the algorithm can also help reduce the cost of diagnosis in conjunction with other products. The Company will charge for this benefit on a per exam basis. The clearance gives behold.ai immediate access to the world’s largest market for medical devices and commercial rollout of the radiology AI solution, in the US, is planned for later this year.
This announcement comes after radiologists at the University Hospitals of Leicester NHS Trust, recently presented to the British Thoracic Oncology Group conference in Dublin the potential of the Behold.ai algorithm for rapid detection of cancerous abnormalities on patients’ medical chest x-rays.
The UK’s Secretary of State for Health Matt Hancock also singled out behold.ai’s groundbreaking AI radiology implementation at Dartford and Gravesham NHS Trust in his ‘vital to have for the NHS’ speech.
“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 USA to validate the performance of the algorithm,” said Chief Executive Simon Rasalingham. “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.”