Image: AI-Guided Imaging Software (Photo courtesy of Caption Health)
A new study has demonstrated that ultrasound images captured by nurses using FDA-approved AI-guided medical imaging acquisition software without prior ultrasound experience and reviewed by experienced cardiologists were of diagnostic quality.
The study examined Caption Health’s (Brisbane, CA, USA) Caption AI platform, which includes Caption Guidance and Caption Interpretation, which is the first and only AI-guided medical imaging acquisition software to obtain FDA clearance, enabling a broad range of healthcare workers to perform cardiac ultrasound examinations at the point of care. The study demonstrated that ultrasound images captured by nurses without prior ultrasound experience and reviewed by experienced cardiologists were shown to be of diagnostic quality to assess left ventricular size and function in 98.8% of patients, right ventricular size and function in 92.5% of patients, and in 98.8% of patients for presence of pericardial effusion. The study was conducted with 240 patients aged 20-91, 42% female patients, with 17.6% of patients Black or African-American, and 33% of patients with a BMI of 30 or greater.
Each patient in the study underwent paired ultrasounds: one from a nurse, and one from an experienced registered diagnostic cardiac sonographer. In addition to evaluating diagnostic quality, the cardiologists also made diagnostic assessments. For the diagnostic assessments corresponding to the primary endpoints listed above, there was at least 92.5% agreement between the nurse and sonographer scans. The results indicated that Caption Guidance performed well for patients with various cardiac pathologies that might be encountered in real-world clinical practice; more than 90% of patients were found to have cardiac abnormalities in scheduled full echocardiograms performed within two weeks of the study. The results were also consistent across BMI, sex, and race, further demonstrating Caption Guidance's efficacy and robustness.
"This study shows that AI-guided imaging can expand healthcare professionals' skill sets in a meaningful way with minimal training - giving patients more opportunities to receive timely diagnostic care," said Yngvil Thomas, Head of Medical Affairs & Clinical Development at Caption Health.
"The study's remarkable agreement between nurses' scans and sonographers' scans shows that the use of AI like Caption Guidance could fundamentally change how we use medical imaging," said Dr. Akhil Narang, a cardiologist at Northwestern Medicine and first author on the paper. "This will extend the abilities of healthcare providers to evaluate for different pathologies in critical care, emergency departments and other settings - and perhaps identify them even earlier with the assistance of AI."