LONDON – The US Food and Drug Administration (FDA) has 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.

‘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 immediate access to the world’s largest market for medical devices. Commercial rollout in the US is planned for later this year.

This announcement follows a number of other recent highlights at the Company:

  • 28 January – Secretary of State for Health Matt Hancock singled out’s groundbreaking AI implementation at Dartford and Gravesham NHS Trust in his ‘vital to have for the NHS’ speech
  • 29 January – radiologists at the University Hospitals of Leicester NHS Trust presented to the British Thoracic Oncology Group conference in Dublin the potential of the algorithm for rapid detection of cancerous abnormalities on patients’ medical chest x-rays
  • 2 February –’s technology was showcased at the Artificial Intelligence in Clinical Radiology & Medical Imaging Conference in Birmingham

“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.”


For further information, please contact: John Wright on 07710 454214 or email:


About and radiology provides artificial intelligence, through its red dot® cognitive computing platform, to radiology departments. This technology augments the expertise of radiologists to enable them to report with greater clinical accuracy, faster and more safely than they could before. This revolutionary combination helps to deliver greater performance in radiology reporting at a fraction of the price of outsourced reporting.

Radiology departments play an essential role in the diagnostic process; however, a consequence of fewer radiologists and a growing demand for images has left services stretched beyond capacity across many trusts, resulting in reporting delays – in some cases impacting cancer diagnosis. These service issues have been highlighted by the Care Quality Commission and the Royal College of Radiologists.

Our solution seamlessly integrates into local trust workflows augmenting clinical practice and delivering state-of-the-art, safe, Artificial Intelligence.

The algorithm has been developed using more than 30,000 example images, all of which have been reviewed and reported by highly experienced consultant radiology clinicians in order to shape accurate decision making. The red dot® prioritisation platform is capable of sorting images into normal and abnormal categories in less than 30 seconds post image acquisition. and quality

Apart from FDA clearance, is also in the final stages of CE mark Class IIa certification.

In September 2019 the Company was awarded ISO 13485 QMS certification for an AI medical device – the ‘gold standard’ of quality certification.