FDA Approves Software That Allows HCPs Without Prior Experience to Perform Cardiac Ultrasound

The FDA has authorized marketing of Caption Guidance software (Caption Health) to assist medical professionals in the acquisition of cardiac ultrasound images.

The Food and Drug Administration (FDA) has authorized marketing of Caption Guidance software (Caption Health) to assist medical professionals in the acquisition of cardiac ultrasound images. 

Caption Guidance is used as an accessory to compatible diagnostic ultrasound systems to capture images of a patient’s heart using artificial intelligence. It is indicated for use in ultrasound examination of the heart, known as 2-dimensional transthoracic echocardiography (2D-TTE), for adult patients, specifically in the acquisition of standard views of the heart from different angles. 

The software offers prescriptive guidance to allow the user to capture optimal images by emulating the guidance of an expert sonographer. It enables healthcare professionals, with or without prior ultrasound experience, to perform accurate ultrasound exams. The machine learning software provides real-time feedback to users on how to maneuver the ultrasound probe to differentiate between acceptable and unacceptable image quality. It will also automatically capture and save video clips acquired from the exam. At the end of examination, a cardiologist should still review the final images and videos for evaluation.

The marketing authorization was supported by data from 2 independent studies that involved the use of Caption Guidance. In particular, a multicenter prospective clinical trial conducted at Northwestern Medicine and Minneapolis Heart Institute at Allina Health evaluated 8 registered nurses with no prior ultrasound experience to perform ultrasound exams on 240 patients. 

Results showed that Caption Guidance met all 4 primary end points, which were assessed by a panel of 5 expert cardiologists. The nurses successfully acquired qualitative visual assessments of left ventricular size (98.8%; 95% CI, 97.6-100); left ventricular function (98.8%; 95% CI, 97.6-100); right ventricular size (92.5%; 95% CI, 88.1-96.9); and pericardial effusion (98.8%; 95% CI, 97.7-100).

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“Echocardiograms are one of the most widely-used diagnostic tools in the diagnosis and treatment of heart disease,” said Robert Ochs, PhD, deputy director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Today’s marketing authorization enables medical professionals who may not be experts in ultrasonography, such as a registered nurse in a family care clinic or others, to use this tool. 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.”

For more information visit captionhealth.com.