Caption Health AI System Gets EU Nod

Caption Health recently announced it has received a CE Mark for its Caption AI (artificial intelligence) technology platform. The certification indicates that the technology has met the European Union’s safety, health, and environmental protection requirements and can be traded freely in any part of the European Economic Area, regardless of its country of origin. The company, which describes itself as a leader in using AI and services to improve heart ultrasound access, highlighted that this certification creates the opportunity to make its technology platform available outside of the US.

“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 (EU MDR) process,” said Tahir Rizvi, head of regulatory affairs and quality assurance at Caption Health. “Our strong clinical foundation facilitated a seamless pathway towards certification through the EU MDR clinical evaluation requirements. 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.”

Cardiovascular diseases are the leading cause of death globally, taking an estimated 17.9 million lives each year, according to the World Health Organization. A 2021 report by NHS England showed that UK patients in need of non-obstetric ultrasound waited longer than for any other diagnostic test, with nearly 20% waiting six weeks or more. The NHS also estimates that cardiovascular disease, which causes a quarter of all deaths, has the biggest area to mitigate morbidity and mortality over the coming decade. The biggest mitigation strategy is early detection.

The company states that the system makes diagnostic care more assessable, cost-effective, and convenient for at-risk patients, even before signs of heart failure are detected.

The technology is fully encrypted, adheres to HIPAA privacy standards, can be securely downloaded, and is updated regularly to ensure data is protected. Caption AI has been widely available in the US since its FDA clearance in 2020, has been published in multiple peer-reviewed journals, and clinical trials.

“Our technology harnesses the power of ultrasound and allows diagnostic images to be acquired wherever the patient may be,” said Randolph P. Martin, MD, chief medical officer of Caption Health. “Earlier detection of cardiac issues allows us to impact the course of disease and improve outcomes. 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.”

Original Article: (https://www.mddionline.com/regulatory-quality/caption-health-ai-system-gets-eu-nod)