Caption Health received De Novo clearance from the FDA for its AI-assisted cardiac ultrasound software

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Digital health startup Caption Health received De Novo clearance from the FDA for its AI-powered Caption Guidance tool that guides medical professionals as they perform echocardiogram tests that would otherwise require an ultrasound expert, according to MobiHealthNews.

For context, a De Novo marketing authorization establishes a new classification category for low-to moderate-risk, first-of-a-kind products, per MedTechDive. The Caption Guidance software is indicated for use in adult patients for the acquisition of standard views of the heart from different angles, according to the FDA.

Here's how both patients and providers could benefit from Caption Health's cardiac ultrasound tool:

• The tool eliminates the need for a specalist given its ability to guide practitioners in real time, making it possible to perform more tests and aiding in the early detection of heart disease. As a wider range of medical pros are able to leverage the Caption Guidance tool, more diagnostic tests can be run, enabling providers to catch and treat the symptoms of heart disease earlier - and this could be an attractive proposition to health systems, as catching and treating symptoms earlier could help clamp down on the massive costs associated with heart disease and improve health outcomes. Heart disease is the leading cause of death among men and women in the US, per the CDC, and costs the US $200 billion annually.
• And getting the software into the hands of more medical staff could alleviate burnt out specialists. By expanding the scope of medical staff who are able to conduct diagnostic imaging, overburdened specialists could see some much-needed relief: With over 57% of US specialists saying they're burned out, getting the Caption Guidance tool into the hands of nonexpert medical staff could be a good first step in alleviating providers' significant work burden and stress. And the capabilities of the Caption Guidance tool can help streamline the diagnostic process so that providers are spending less time on these tasks.

The development highlights the latest in a series of moves among digital health players making it easier to detect and treat cardiovascular diease. In September 2019, Alphabet's life sciences division, Verily, teamed up with San Francisco-based iRhythm - maker of clinical-grade continuous electrocardiogram patches - to develop a monitor for asymptomatic atrial fibrillation.

And in November 2019, UK-based health tech firm Ultromics received FDA clearance for its cardiovascular image analysis system, EchoGo Core, which applies AI to automate the analysis of ultrasound-based heart scans, per MobiHealthNews.

With cardiovascular disease costs projected to exceed $1 trillion by 2035, per ScienceDaily, we expect to see digital health players double down on their cardiovascular diagnostics efforts - and traditional players like health systems will likely make room for AI-enabled tools that lead to improved prevention of heart disease, and the savings that would accompany early detection.

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