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# Caption Health AI Cardiac Imaging Software Cleared
- URL: https://www.fdaweb.com/caption-health-ai-cardiac-imaging-software-cleared/
- Published: 2020-02-07T12:00:00.000Z
- Updated: 2026-09-14T16:02:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146047

FDA has permitted the de novo marketing of Caption Health’s software to assist medical professionals in capturing cardiac ultrasound or echocardiography images. The software, called Caption Guidance, is considered an accessory to compatible diagnostic ultrasound systems and uses artificial intelligence to help users capture images of a patient’s heart that are of acceptable diagnostic quality, according to an FDA release.  

The software is indicated for use in ultrasound two-dimensional transthoracic echocardiography for adult patients, such as standard heart views from different angles. “These views are typically used in the diagnosis of various cardiac conditions,” the agency says.

FDA says the software was developed using “machine learning to train the software to differentiate between acceptable and unacceptable image quality. This knowledge formed the basis of an interactive AI user interface that provides prescriptive guidance to users on how to maneuver the ultrasound probe to acquire standard echocardiographic images and video clips of diagnostic quality. 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.”