Exo Launches a New Era in Disease Diagnosis with the First FDA-cleared Ultrasound AI for Detection of Pleural Effusion and Consolidation/Atelectasis

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SANTA CLARA, Calif.--(BUSINESS WIRE)--Jun 18, 2025--

Exo (pronounced “echo”), the leader in AI-powered, accessible medical imaging, is transforming lung disease diagnosis with another first. Now included on Exo Iris® is the first ever FDA 510(k) cleared AI for detecting pleural effusion and consolidation/atelectasis. These on-device real-time indicators empower clinicians with objective data to help detect lung diseases like pneumonia and tuberculosis at the bedside in seconds.

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Exo Iris® now automatically detects and localizes key pulmonary findings for emergency care, showing superiority to clinicians alone

Arun Nagdev, MD, Vice President of Clinical Affairs at Exo and a leading POCUS expert, said, “ 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. This is a great support for clinicians looking to diagnose commonly presenting patient symptoms of shortness of breath, coughing, pain, and fatigue.”

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

These clearances mark not only a technical and regulatory milestone, but a meaningful expansion in how Exo is supporting frontline providers and patients when every second counts. Exo remains focused on delivering technology that enables critical decisions instantly, intelligently, and saves lives at scale.

These clearances bring to a remarkable 14, the FDA-cleared AI indicators embedded in Iris. This sweeping portfolio is unmatched in handheld ultrasound today. All commercialized Exo AI runs directly on Exo Iris®, operates without internet, eliminates lag, and enables expert-level diagnostics in any setting. Exo is establishing a new standard in fast, accurate, and scalable point-of-care imaging.

Visit Exo’s website to explore these capabilities.

About Exo

Exo is redefining medical imaging with its advanced ultrasound platform, combining novel silicon-based hardware, tightly coupled AI, and easy-to-use collaboration software. Its handheld and soon-to-be OEM-integrated systems deliver high-performance imaging and real-time clinical intelligence, driving better, more accessible diagnostics and outcomes across diverse care settings.

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KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: TECHNOLOGY MEDICAL DEVICES FDA HEALTH TECHNOLOGY SOFTWARE HARDWARE RADIOLOGY GENERAL HEALTH HEALTH ARTIFICIAL INTELLIGENCE

SOURCE: Exo

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PUB: 06/18/2025 08:55 AM/DISC: 06/18/2025 08:53 AM

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