FDA Clears Path for First AI-Guided Cardiac Ultrasound Software System

An apical two-chamber view of the heart captured by Caption AI. Courtesy: Caption Health

An apical four-chamber view of the heart captured by Caption AI. Courtesy: Caption Health

In a move that will make it easier for providers to capture diagnostic-quality images of a patient’s heart, the U.S. Food and Drug Administration (FDA) green-lighted marketing for Caption Guidance™, the first cardiac ultrasound software that uses artificial intelligence (AI) guidance.

The software, which is used with echocardiograms in adults, received FDA breakthrough device designation in October through the De Novo pathway, a regulatory path reserved for novel technologies.

“Today’s marketing authorization enables medical professionals who may not be experts in ultrasonography, such as a registered nurse in the family care clinic or others, to use this tool,” said Robert Ochs, Ph.D., deputy director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices 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.”

Electrocardiograms, Holter monitors, and cardiac ultrasounds are integral to identifying the possible heart problems responsible for the deaths of approximately 647,000 Americans each year. Caption Guidance, developed by Caption Health, is the first software authorized to guide users through cardiac ultrasound image acquisition.

Trained with machine learning to distinguish between acceptable and unacceptable image quality, the software guides users through the proper way to maneuver the ultrasound probe to capture diagnostic-quality echocardiographic images and videos. An AI interface offers real-time feedback on image quality, and it can automatically capture and save the best video clips. A cardiologist still provides a final assessment on image quality.

Initially, Caption Guidance will be implemented in acute point-of-care settings, including emergency and anesthesiology departments and critical care units, where it can help triage, monitor, and assess patients who present with chest pain, shortness of breath, cardiac arrest, and other heart-related problems. The FDA authorization to do so comes during a time of rapid growth for point-of-care ultrasound.

“Point-of-care ultrasound has been demonstrated to expediate time to diagnosis, reduce the need for more costly testing, and decrease complications from invasive procedures,” said John Bailitz, M.D., System Point of Care Ultrasound Education Director for Northwestern Medicine. “Caption Guidance can unlock these benefits by addressing one of the largest barriers to ultrasound adoption: the ability to acquire diagnostic quality images quickly.”

In a study, conducted by Northwestern Medicine and the Minneapolis Heart Institute at Allina Health, eight registered nurses, who had no prior ultrasound experience and only a short training course, used Caption Guidance to examine 240 patients across a wide variety of cardiac pathologies. Nurses captured 10 views per exam, and five cardiologists analyzed the quality of each exam. Using the software, nurses achieved all four endpoints, acquiring limited echo exams for: left ventricular size (98.8 percent), left ventricular function (98.8 percent), right ventricular size (92.5 percent), and pericardial effusion (98.8 percent).

In an additional study, reviewed by the FDA, 50 trained sonographers scanned patients with and without Caption Guidance assistance. Comparable diagnostic quality images were captured in both settings.

Ultimately, according to company officials, Caption Guidance will extend critical cardiac imaging to a wider population of patients, many of whom do not currently have access.

“No patient should have to forgo a potentially life-saving cardiac ultrasound,” said Andy Page, Caption Health chief executive officer. “Through the power of artificial intelligence, Caption Guidance will provide patients with unprecedented access to ultrasound when and where they need it most.”