AI model for pneumothorax gains FDA clearance

behold.ai, a London-based imaging technology company, has received FDA clearance for its AI algorithm designed to help radiologists triage pneumothorax patients.

The algorithm, red dot, is scheduled to be rolled out to U.S. consumers in the months ahead. Users will be charged on a per-exam basis.

“We are delighted to have received clearance for our algorithm in the U.S.,” Simon Rasalingham, behold.ai chief executive, said in a statement. “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.”

The company said it validated its AI model by applying it to data from more than 800 patients, with a team of three board-certified radiologists confirming its accuracy.

“FDA clearance is not just about safety but also about efficacy,” Rasalingham added. “We believe our technology can make a big difference to patient safety, the delivery of care and cost-savings to the system.”