Caption Health announced today that it received CE mark for its Caption AI cardiac ultrasound technology platform.
Brisbane, California-based Caption Health designed its Caption AI platform to provide a convenient, cost-effective solution for cardiac ultrasound in assessing heart failure.
The platform can be used at scale to detect signs of heart failure in at-risk patients in doctors’ offices and even at home, helping to prevent avoidable hospitalizations and support improved clinical outcomes, according to a news release.
Caption Health said its platform enables medical staff to obtain quick, easy and accurate assessments of cardiac function and ejection fraction wherever patients are located. It received FDA 510(k) clearance in 2020.
“Our technology harnesses the power of ultrasound and allows diagnostic images to be acquired wherever the patient may be. Earlier detection of cardiac issues allows us to impact the course of disease and improve outcomes,” Caption Health CMO Randolph P. Martin said in the release. “This is a big step forward in improving access and addressing the significant unmet need stemming from the increasing global burden of cardiovascular diseases like heart failure and valvular heart disease.”
Tahir Rizvi, the company’s head of regulatory affairs and quality assurance, added that the Caption AI platform is “one of the first” AI-based ultrasound products to garner CE mark through the EU MDR process.
“Our strong clinical foundation facilitated a seamless pathway towards certification through the EU MDR clinical evaluation requirements,” Rizvi said. “This milestone will help us address the increasing global burden of disease from conditions such as heart failure, valvular heart disease, and coronary artery disease.”
About a year ago, Caption Health partnered with handheld ultrasound technology developer Butterfly Network to leverage the Caption AI software. The partnership aims to improve the ease of image capture and image interpretation in a number of care settings, including the hospital, clinic and the home.