Deep Breathe gets FDA clearance for AI that detects absent lung sliding

Deep Breathe Inc. won U.S. FDA clearance for software that uses artificial intelligence to help clinicians assess pneumothorax, a potentially life-threatening air leak around the lung. The Ontario company says the clearance is its second in 12 months and the first for AI dedicated to detecting absent lung sliding.

Why it matters: - Deep Breathe’s clearance could help clinicians spot pneumothorax faster when every minute matters. - The software is designed to bring ultrasound-reading expertise to bedside, ambulance and field settings where trained interpretation can be limited. - The FDA action gives Deep Breathe a stronger path to expand its medical software across healthcare and defence.

What happened: - Deep Breathe Inc. received U.S. Food and Drug Administration clearance for software that uses artificial intelligence to help clinicians assess pneumothorax. - The company is based in London, Ontario, with locations in Toronto and Boston. - The clearance came on October 28, 2026. - Deep Breathe says this is its second FDA clearance in 12 months. - The company says this is the first FDA clearance for AI dedicated to detecting absent lung sliding.

The details: - The AI identifies when lung sliding is absent on lung ultrasound. - Absent lung sliding can alert clinicians to a possible pneumothorax. - Pneumothorax is a condition in which air collects between the lung and chest wall. - Portable ultrasound allows clinicians to examine patients at the bedside, in an ambulance or in the field. - Reading those images takes training and experience. - Deep Breathe’s software is meant to put that expertise directly into clinicians’ hands. - Dr. Robert Arntfield, founder and CEO of Deep Breathe, said: “When you suspect a pneumothorax, you need answers quickly.” - Arntfield said the company is giving clinicians “another set of trained eyes through AI, wherever they’re working.” - The AI technology behind the clearance has been patented. - The technology has been evaluated at the bedside across multiple hospitals. - Military research found that a related application helped U.S. Marine Corps medical personnel with limited ultrasound experience interpret images more accurately. - Deep Breathe received $1 million in Canadian federal support. - NATO DIANA selected Deep Breathe for its Mission Track defence innovation program.

Between the lines: - The clearance suggests regulatory momentum for Deep Breathe after a second FDA win in a year. - The company is positioning the same core technology for both hospital care and defence use cases. - The mix of bedside testing, military research and federal support gives the product more credibility for buyers who want evidence beyond the lab.

What's next: - Deep Breathe says the milestones should help it bring the software to more customers across healthcare and defence. - The company also directs users to learn more. - Deep Breathe maintains social channels on LinkedIn, YouTube and X.