After expanding the use of its artificial intelligence programs for guiding U.S. clinicians through ultrasound exams of the heart, Caption Health is taking its software overseas with its first green light in Europe.
The company received a CE Mark for its Caption AI platform, which helps walk even untrained technicians through cardiac ultrasound scans—a potentially tricky procedure that requires precise hand movements to produce clear images capable of diagnosing heart disease.
"Our technology harnesses the power of ultrasound and allows diagnostic images to be acquired wherever the patient may be,” Caption’s chief medical officer, Randolph Martin, said in a statement.
The former Fierce Medtech Fierce 15 winner cited figures from the World Health Organization, which estimates that cardiovascular disease causes the deaths of almost 18 million people worldwide each year.
Caption also pointed to a 2021 report from the U.K. National Health Service, which listed non-obstetric ultrasound exams as having the longest wait times of any diagnostic test, with many taking several weeks to schedule. The NHS also estimates that cardiovascular disease causes a quarter of all deaths.
By alleviating the need for a specialist to conduct the exam in person, Caption hopes to get patients to a confirmed diagnosis sooner rather than later. Through an echocardiogram that measures the heart’s ability to pump blood efficiently out to the rest of the body, it can help identify the early signs of heart failure, as well as valve disease and potentially blocked coronary arteries.
"Our platform is one of the first AI-based ultrasound products to obtain a CE Mark through the robust and comprehensive European Medical Device Regulation process,” said Tahir Rizvi, Caption’s head of regulatory affairs and quality assurance.
The European expansion comes shortly after Caption announced a plan to outfit mobile diagnostic services with its technology in the U.S., in keeping with the trend of healthcare moving outside the hospital.
Through a partnership with Portamedic, the companies’ Caption Care service aims to provide at-home ultrasound visits, providing what Caption describes as the “last mile” separating people from more convenient and accessible exams.