First AI-enabled POCUS app for detecting pleural effusion and atelectasis earns FDA clearance

The U.S. Food and Drug Administration just cleared an artificial intelligence tool that has the potential to change how life-threatening lung conditions are diagnosed in emergency settings. 

Exo—a company that specializes in developing AI-enabled tools to improve medical imaging accessibility—announced the FDA clearance of two new AI apps that can be integrated into its point of care ultrasound (POCUS) device, Exo Iris. The apps are the first to achieve FDA clearance for detecting pleural effusion and consolidation/atelectasis, which can be deadly if not identified in a timely manner. 

Vice President of Clinical Affairs at Exo and a leading POCUS expert, Arun Nagdev, MD, described the capabilities of the apps as “groundbreaking” for bedside emergency care. 

“This groundbreaking real-time AI provides a remarkable assist for all clinicians at the bedside, instantly and accurately detecting fluid around the lungs or areas of collapsed lung, key markers for significant infections like pneumonia or tuberculosis,” Nagdev said in an announcement. “This is a great support for clinicians looking to diagnose commonly presenting patient symptoms of shortness of breath, coughing, pain, and fatigue.” 

Exo Iris is plugged directly into a smartphone, and the embedded apps can be utilized anywhere and without the internet. In clinical testing, the newly cleared apps helped providers identify the lung conditions with sensitivity levels in the “excellent” range, significantly improving their performances. The ability for the device to be easily transported in something as small as a pocket expands access to providers and patients in need of timely diagnosis and treatment.  

“We’re thrilled to bring these FDA-cleared firsts to all clinicians and to meaningfully impact patient diagnosis and outcomes when it matters most,” Exo’s VP of AI, Dornoosh Zonoobi, said in the same announcement. 

This latest clearance brings the total number of Exo’s FDA-cleared AI indicators to 14. Its other AI applications target a wide range of conditions of the heart, lungs, bladder, hips and thyroid. 

Learn more about Exo’s POCUS portfolio here. 

Hannah murhphy headshot

In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.

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