FDA Approves AI Ultrasound Software

The US Food and Drug Administration (FDA) authorized marketing to Caption Health for its artificial intelligence (AI)-based software that helps providers acquire cardiac ultrasound images.

The technology, Caption Guidance, provides real-time guidance and diagnostic quality assessment of images. Providers with and without prior ultrasound experience can use Caption Guidance and capture diagnostic quality images.

Caption Guidance has the potential to allow more patients to benefit from ultrasound, improve and standardize the quality of care, and help facilities save time and money.

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

The marketing authorization came after the FDA reviewed extensive performance testing. The agency looked at data from a multi-center prospective clinical trial which was conducted by Northwestern Medicine and Minneapolis Heart Institute at Allina Health.

During the study, 8 registered nurses with no prior ultrasound experience evaluated the use of Caption Guidance. The nurses participated and in a short training course and then used the technology to perform ultrasound exams on 240 patients. A panel of 5 expert cardiologists assessed each exam to determine if its quality was sufficient enough to make a set of specific qualitative visual assessments.

Caption Guidance met all 4 primary endpoints. The nurses successfully acquired limited echo exams for qualitative visual assessments of left ventricular size (98.8%; 95% CI, 96.7-100); left ventricular function (98.8%; 95% CI, 96.7-100); right ventricular size (92.5%; 95% CI, 88.1-96.9); and pericardial effusion (98.8%; 95% CI, 96.7-100).

The software will initially be deployed in acute point-of-care settings like emergency and anesthesiology departments and critical care units. Caption Guidance could then expand to additional departments in the future.

The FDA granted Breakthrough Device designation to Caption Guidance in 2018, which meant the AI-based software could provide a more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition.