FDA Awards 510(k) Clearance to Immediate Diagnostic for Pneumothorax

March 18, 2020

Behold.ai receives approval for red dot® imaging recognition algorithm.

London-based Behold.ai received 510(k) clearance from the U.S. Food & Drug Administration this week for its automatic diagnosis tool for pneumothorax.

Referring to the tool as an “instant triage,” the company said its red dot® algorithm alerts radiologists as soon as it captures a pneumothorax on a X-ray image.

According to a company statement, the tool not only saves reading time, but it can also help reduce the cost of diagnosis when used in conjunction with other products.

“FDA clearance is not just about safety, but also about efficacy,” said Behold.ai Chief Executive Officer Simon Rasalingham, in a press statement. “We believe our technology can make a big difference to patient safety, the delivery of care and cost-savings to the system.”

Based on company information, customers will be charged on a per exam basis, and red dot® will be commercially available in the United States later this year.