The Caption AI platform, which incorporates Caption Guidance and Caption Interpretation, is the first and only AI-guided medical imaging acquisition software to secure FDA clearance, allowing for a vast range of healthcare workers to perform cardiac ultrasound examinations at the point of care.
Fremont, CA: Caption Health, a leading medical artificial intelligence (AI) company providing AI guidance and interpretation for ultrasound, has declared the publication of the study that was the basis for the February 2020 authorization of Caption Guidance via the FDA's De Novo pathway. The Caption AI platform, which incorporates Caption Guidance and Caption Interpretation, is the first and only AI-guided medical imaging acquisition software to secure FDA clearance, allowing for a vast range of healthcare workers to perform cardiac ultrasound examinations at the point of care.
Published in JAMA Cardiology, the study shows that ultrasound images captured by nurses without past ultrasound experience and reviewed by experienced cardiologists were shown to be of diagnostic quality to evaluate left ventricular size and function in 98.8 percent of patients, right ventricular size and function in 92.5 percent of patients, and in 98.8 percent of patients for the presence of pericardial effusion. The study was conducted with 240 patients aged 20-91, 42 percent female patients, with 17.6 percent of patients Black or African-American, as well as 33 percent of patients with a BMI of 30 or greater.
"In our mission to democratize access to healthcare and quality medical imaging, we wanted to ensure that we tested Caption Guidance on a wide range of patients to prove its effectiveness across a diverse population," stated Yngvil Thomas, Head of Medical Affairs & Clinical Development at Caption Health. "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."
"Cardiac ultrasound is a powerful diagnostic technology that can be helpful, and even life-saving, in many clinical settings," stated Dr. Chris Moore, an emergency medicine physician at Yale. "However, its application may be limited by the availability of experienced users. This groundbreaking study represents a significant step forward in making this technology more widely accessible to patients wherever needed."