Exo Wins FDA Nod for AI to Spot Pleural Effusion, Consolidation/Atelectasis

Exo has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for a new application on Exo Iris—artificial intelligence (AI) to detect pleural effusion and consolidation/atelectasis.

The on-device, real-time indicators provide objective data to detect lung diseases like pneumonia and tuberculosis at the bedside in seconds, the company said. According to Exo, it’s the first FDA-cleared device of its kind.

The clearance brings the number of authorized AI indicators embedded in Iris to 14, a portfolio the company said is unmatched in handheld ultrasound today. In April, the company won an FDA nod for its Exo Iris ultrasound—Global Longitudinal Strain (GLS) analysis, which provides objective data to help spot heart failure and chemotherapy-induced cardiotoxicity in seconds.

Exo AI runs directly on Exo Iris, operates without internet, removes lag, and allows expert-level diagnostics in any setting, the company said. The ultrasound platform combines silicon-based hardware, tightly coupled AI, and collaboration software.

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“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,” said Exo VP of clinical affairs Arun Nagdev, MD. “This is a great support for clinicians looking to diagnose commonly presenting patient symptoms of shortness of breath, coughing, pain, and fatigue.”

“Validated in rigorous clinical studies, these AIs enabled clinicians to detect key lung findings, with sensitivity and specificity in the ‘excellent’ range,” added Exo’s VP of AI Dornoosh Zonoobi. “We’re thrilled to bring these FDA-cleared firsts to all clinicians and to meaningfully impact patient diagnosis and outcomes when it matters most.”