Caption Health receives regulatory approvals for Caption AI™ technology platform in Canada and Australia

Recent approvals position Caption to make a broader impact on global health through increased access to innovative heart health technology

BRISBANE, California., November 10, 2022 /PRNewswire/ — Lettering healththe leading provider of AI and services to improve access to cardiac ultrasound diagnostics, announced new regulatory approvals to commercialize its Caption AI™ technology platform from Health Canada’s Medical Devices Directorate and Australia remedy administration. Echocardiography is the preferred initial imaging modality for evaluating patients with suspected heart failure, and Caption Health anticipates that its global growth will enable widespread access to earlier and more accurate heart care, particularly in underserved populations and geographies, as has already begun in the United States

These are the second and third international regulatory approvals for Caption AI this year, following the announcement of European CE Marking this summer. The platform, which received its first regulatory approval from the U.S. Food and Drug Administration in 2020, enables any healthcare professional to perform a cardiac ultrasound with no prior ultrasonography experience. Over the past year, the company launched its Caption Care service – bringing innovative diagnostic imaging to clinics and homes at scale for the first time – and worked with a number of companies to expand the impact of disease early detection and management to optimize heart failure.

“Our strategic global expansion is about more than market access, it’s about patient access,” he said Steve Cashman, CEO of Caption Health. “For the first time, we have the opportunity to improve and even save millions of lives by using cutting-edge technology to detect heart problems before they become persistent. We are excited to take these next steps.”

Broader access to cardiac ultrasound is critical to global health, experts say 64 million people worldwide – and increasing – have heart failure. Because symptoms typically don’t appear until late in the disease, heart failure is often diagnosed in a hospital after the advanced disease has led to an emergency. Despite the benefits of early detection, patients in some Canadian provinces may lose more than one year Waiting for an echocardiogram.

And while early intervention can stop or slow progression and save lives, geography often determines outcomes: For example, heart failure is endemic and The resulting mortality is high among Indigenous Australians living in rural areas.

“These new approvals are further validation of our strong clinical and regulatory record and a leading indicator of our potential for growth as we work to reduce the global burden of heart disease,” he said Tahir Rizvi, Head of Regulatory Affairs and Quality Assurance at Caption Health. “We will continue to execute on this strategy and expect to expand into new markets such as Canada next year.”

Caption Health is a sponsor of HLTH 2022. Find out more and book a live demo at booth 541:

About Lettering Health

Caption Health developed the AI ​​platform that enables access to cardiac ultrasound for early disease detection – when it has the greatest potential for impact. The Company’s Caption Care services provide healthcare providers, payers and value-based care organizations with convenient and cost-effective echoes for their members by leveraging the Caption AI technology platform. In 2021, Caption Health was recognized as one of TIME’s 100 Greatest Inventions and a winner of Fast Company’s Next Big Things in Tech for Health. Caption Health’s platform is used in leading hospitals, clinics and physician organizations and is cited in several peer-reviewed journals including JAMA Cardiology and Journal of the American Society of Echocardiography. For more information visit

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SOURCE Caption Health


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