Caption Health gains FDA approval for updates to its cardiac AI system

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Caption AI software in action showing a successful ultrasound.

Caption Health, a developer of medical artificial intelligence (AI) technology, has received US Food and Drug Administration (FDA) 510(k) clearance for an updated version of Caption Interpretation, which enables clinicians to obtain quick, easy and accurate measurements of cardiac ejection fraction (EF) at the point of care.

Left ventricular ejection fraction is one of the most widely used cardiac measurements and is a key measurement in the assessment of cardiac function across a spectrum of cardiovascular conditions.

Caption Interpretation applies end-to-end deep learning to automatically select the best clips from ultrasound exams, perform quality assurance and produce an accurate EF measurement. The technology incorporates three ultrasound views into its fully automated ejection fraction calculation: apical 4-chamber (AP4), apical 2-chamber (AP2) and the readily-obtained parasternal long-axis (PLAX) view—an industry first. While ejection fraction is commonly measured using the more challenging apical views, the PLAX view is often easier to acquire at the point of care in situations where patients may not be able to turn on their sides, such as intensive care units, anaesthesia pre-operative settings and emergency rooms.

“Developing artificial intelligence that mimics an expert physician’s eye with comparable accuracy to automatically calculate EF—including from the PLAX view, which has never been done before—is a major breakthrough,” said Roberto M Lang, professor of  medicine and radiology at the University of Chicago Medicine (Chicago, USA). “Whether you are assessing cardiac function rapidly, or looking to monitor changes in EF in patients with heart failure, Caption Interpretation produces a very reliable assessment.”

“We are pleased to have received FDA clearance for our latest AI imaging advancement—our third so far this year,” said Randolph P  Martin, chief medical officer of Caption Health, emeritus professor of cardiology at Emory University School of Medicine (Atlanta, USA). “An accurate EF measurement is an indispensable tool in a cardiac functional assessment, and this update to Caption Interpretation makes it easier for time-constrained clinicians to incorporate it into their practice.”

Caption Interpretation works in tandem with Caption Guidance, cleared by the FDA earlier this year, as part of the Caption AI platform. Caption Guidance emulates the expertise of a sonographer by providing over 90 types of real-time instructions and feedback. These visual prompts direct users to make specific transducer movements to optimise and capture a diagnostic-quality image. In contrast, use of other ultrasound systems requires years of expertise to recognise anatomical structures and make fine movements, limiting access to clinicians with specialized training.

The company recently closed its Series B funding round with US$53 million to further develop and commercialise its technology.


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