FDA Market-Approves First AI-Based Echocardiography Software

February 07, 2020

The US Food and Drug Administration (FDA) has granted marketing approval to what it calls the first echocardiography software that uses artificial intelligence (AI) "to guide users through cardiac ultrasound image acquisition," the agency announced today.

Although the AI-based software, called Caption Guidance (Caption Health), will initially be limited for use with an approved echocardiography system from the Teratech Corporation, it can potentially be used with other technically compatible systems, the FDA said. It's indicated for transthoracic 2D echocardiography in adults.

Notably, the software is designed to allow clinicians "who may not be experts in ultrasonography, such as a registered nurse in a family care clinic or others," to obtain diagnostic-quality echocardiograms.

"The AI interface provides real-time feedback on potential image quality, can auto-capture video clips, and automatically saves the best video clip acquired from a particular view," the FDA notice states. "Importantly, the cardiologist still reviews the images for a final assessment of the images and videos for patient evaluation."

That the software could allow nonexpert clinicians to obtain useful 2D echocardiograms "demonstrates the potential for artificial intelligence and machine learning technologies to increase access to safe and effective cardiac diagnostics that can be life-saving for patients."

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