FDA Clears Ultrasound AI Detection for Pleural Effusion and Consolidation

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The 14th FDA-cleared AI software embedded in the Exo Iris ultrasound device reportedly enables automated detection of key pulmonary findings that may facilitate detection of pneumonia and tuberculosis in seconds.

The Food and Drug Administration (FDA) has granted 510(k) clearance for ultrasound-based artificial intelligence (AI) software to detect pleural effusion and consolidation/atelectasis.

Exo said the AI software, which is available on the Exo Iris handheld ultrasound device, provides automated detection of pertinent pulmonary markers that may enable clinicians to recognize lung diseases such as pneumonia and tuberculosis in seconds.

FDA Clears Ultrasound AI Detection for Pleural Effusion and Consolidation

Offering automated detection of key pulmonary findings such as pleural effusion, the newly FDA-cleared software on the Exo Iris handheld ultrasound device may facilitate more timely diagnosis of lung disease such as pneumonia and tuberculosis, according to Exo, the developer of the AI software. (Image courtesy of Exo.)

“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,” noted Arun Nagdev, M.D., a vice president of clinical affairs at Exo.

Exo said the new AI software is the 14th AI software to be cleared by the FDA for use on the Exo Iris handheld device.

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