The US Food and Drug Administration (FDA) has authorised marketing of software to assist in the acquisition of cardiac ultrasound, or echocardiography, images. The software, called Caption Guidance (Caption Health), is an accessory to compatible diagnostic ultrasound systems and uses artificial intelligence (AI) to help the user capture images of a patient’s heart that are of acceptable diagnostic quality.
Caption Guidance was authorised via the De Novo pathway, a regulatory pathway reserved for novel technologies. The granting of this De Novo is groundbreaking, as Caption Guidance is the first medical software authorised by the FDA that provides real-time AI guidance for medical imaging acquisition, Caption Health said in a press release.
The Caption Guidance software is indicated for use in ultrasound examination of the heart, known as two-dimensional transthoracic echocardiography (2D-TTE), for adult patients, specifically in the acquisition of standard views of the heart from different angles. These views are typically used in the diagnosis of various cardiac conditions.
“Echocardiograms are one of the most widely-used diagnostic tools in the diagnosis and treatment of heart disease,” said Robert Ochs, 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 authorisation 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.”
“We founded Caption Health to tackle head-on some of the most challenging, intractable problems in medicine,” said Charles Cadieu, co-founder and president of the company. “This FDA authorisation confirms our unique ability to couple breakthrough technology with robust clinical validation. And we’re just getting started.”
Caption Guidance will initially be deployed in acute point-of-care settings, including emergency and anaesthesiology departments and critical care units, with plans to expand to additional departments.
Marketing authorisation was granted after the FDA reviewed extensive performance testing, including data from a pivotal multicentre prospective clinical trial conducted by Northwestern Medicine (Chicago, USA) and Minneapolis Heart Institute at Allina Health (Minneapolis, USA), evaluating the use of Caption Guidance by registered nurses (RNs) with no prior ultrasound experience. Caption Guidance successfully met its primary endpoints, meeting the pre-specified criteria for study success.
In this study, eight RNs with no prior ultrasound experience used Caption Guidance to perform ultrasound exams on 240 patients, following a short training course. Patients were stratified to include a wide range of body-mass index and cardiac pathologies. The RNs acquired limited echo exams of 10 views each. Each exam was assessed by a panel of five expert cardiologists to determine if the exam was of sufficient quality to make a set of specific qualitative visual assessments.
Caption Guidance successfully met all four primary endpoints, meeting the pre-specified criteria for study success by acquiring images of sufficient quality for specific clinical assessments. Namely, the RNs 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% [96.7, 100]; right ventricular size: 92.5% [88.1, 96.9]; and pericardial effusion: 98.8% [96.7, 100].
“Point-of-care ultrasound has been demonstrated to expedite time to diagnosis, reduce the need for more costly testing, and decrease complications from invasive procedures,” said John Bailitz, system point of care ultrasound education director, Northwestern Medicine (Chicago, USA). “Caption Guidance can unlock these benefits by addressing one of the largest barriers to ultrasound adoption: the ability to acquire diagnostic quality images quickly.”