November 10, 2022

Caption Health Receives Regulatory Approvals for Caption AI™ Technology Platform in Canada and Australia

Latest approvals position Caption to broadly impact global health by improving access to innovative heart health technology

BRISBANE, Calif., Nov. 10, 2022 /PRNewswire/ -- Caption Health, the leader in using AI and services to improve access to heart ultrasound diagnostics, announced new regulatory approvals to market its Caption AI™ technology platform from Health Canada's Medical Devices Directorate and Australia's Therapeutic Goods Administration. Echocardiography is the preferred initial imaging modality for evaluation of patients with suspected heart failure, and Caption Health expects its global growth will enable widespread access to earlier and more accurate cardiac care, especially within underserved populations and regions, as it has begun to do in the U.S.

These are the second and third international regulatory approvals this year for Caption AI, following this summer's European CE Mark announcement. The platform, which received its first regulatory clearance through the U.S. Food and Drug Administration in 2020, empowers any health professional to perform a heart ultrasound without prior sonography experience. Over the past year, the company has launched its Caption Care service – bringing innovative diagnostic imaging into clinics and homes at scale for the first time – and partnered with a range of companies to expand the impact of early disease detection and optimize heart failure management.

"Our strategic global expansion is about more than market access, it's about patient access," said Steve Cashman, CEO of Caption Health. "For the first time, we have the opportunity to improve and even save millions of lives using cutting-edge technology to identify heart health issues before they become intractable. We're thrilled to be taking these next strides."

Broader access to heart ultrasound is critical for global health, as experts estimate 64 million people worldwide – and rising – have heart failure. Because symptoms typically don't arise until late-stage disease, heart failure is commonly diagnosed in a hospital after advanced disease leads to an emergency. Despite the benefits of early detection, in some Canadian provinces, patients can lose more than a year waiting for an echocardiogram.

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

"These new approvals are further confirmation 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," said Tahir Rizvi, Head of Regulatory Affairs and Quality Assurance at Caption Health. "We will continue to execute this strategy and expect to make an impact immediately in new markets like Canada next year."

Caption Health is a sponsor of HLTH 2022. Learn more and book a live demo at Booth 541:

About Caption Health

Caption Health has developed the AI platform that enables heart ultrasound access for early disease detection – when there is the highest potential for impact. The company's Caption Care services offer health providers, payers, and value-based care organizations convenient and cost-effective echos for their members, leveraging its Caption AI technology platform. In 2021, Caption Health was recognized as one of TIME's 100 Best Inventions and a winner of Fast Company's Next Big Things in Tech for health. Caption Health's platform is used at 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