The FDA announced today that it has authorized the marketing of Caption Health’s Caption Guidance software for assisting in the acquisition of cardiac ultrasound or echocardiography images.
Caption Guidance is an accessory to compatible diagnostic ultrasound systems designed to use artificial intelligence to help capture images of a patient’s heart that are of acceptable diagnostic quality, according to an FDA news release.
The software enables medical professionals who may not be experts in ultrasonography, such as registered nurses in family care clinics, to use diagnostic ultrasound, said Robert Och, FDA Center for Devices and Radiological Health deputy director of in vitro diagnostics and radiological health.
“This is especially important because it 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,” Och said in a news release.
Caption Health CEO Andy Page said: “No patient should have to forgo a potentially life-saving cardiac ultrasound. Through the power of artificial intelligence, Caption Guidance will provide patients with unprecedented access to ultrasound when and where they need it most.”
The software is indicated for use in ultrasound examination of the heart, or two-dimensional transthoracic echocardiography (2D-TTE) for adult patients. It’s indicated specifically for the acquisition of standard views of the heart from different angles that are used in the diagnosis of multiple cardiac conditions.
Using machine learning, Caption Guidance is able to differentiate between acceptable and unacceptable image quality to form the basis of an interactive AI interface. The interface provides real-time feedback on potential image quality, can auto-capture video clips and automatically saves the best clip acquired from a particular view.
Currently, healthcare professionals can use the software with a specific FDA-cleared diagnostic ultrasound system produced by Teratech. It has the potential to be used with other ultrasound systems with technical specifications consistent with the range of systems used as part of the development and testing.
The FDA evaluated data from two different studies to review the device application. One study included 50 trained sonographers who were able to capture comparable diagnostic quality images both with and without the assistance of Caption Guidance.
In the other study, eight registered nurses who are not sonography experts used the software and were asked to capture standard echocardiography images. Five cardiologists assessed the quality of the images and the results showed that the Caption Guidance software enabled the nurses to acquire images of diagnostic quality.
Caption Health was previously known as Bay Labs before a rebrand in October 2019. Prior to the rebranding, the Caption Guidance software was known as EchoGPS.