Sky Labs recently, has received the European Union’s Medical Device Regulation (CE-MDR) certification for its ring-type blood pressure monitoring solution, the Cart Platform. The certification covers the entire ecosystem, including the ring-type medical device equipped with photoplethysmography (PPG) sensors, the patient-facing mobile application, backend server infrastructure, and the web-based monitoring viewer used by medical professionals.

Designed to enable continuous and convenient blood pressure management, the moniter measures blood pressure and other vital signs, including irregular pulse detection. Patients wear the ring device to collect physiological data, which is delivered via a mobile app, while healthcare providers can remotely access and monitor patient data through a dedicated web viewer.

Commenting on the development, Jack Byunghwan Lee, CEO of Sky Labs, said, “Securing the CE-MDR certification is more than a technical approval; it reflects global trust in our technology and our ability to meet the stringent regulatory standards of the European medical market. Leveraging our unique cuffless blood pressure monitoring technology, we aim to accelerate our expansion in the global healthcare landscape.”

The solution is positioned as an alternative or complement to traditional 24-hour cuff-based blood pressure monitoring, which is often associated with discomfort and limited patient compliance. By offering cuffless, continuous monitoring, the platform aims to improve patient experience while supporting more efficient hypertension management.

The technology has already demonstrated clinical and commercial traction in South Korea. Since receiving insurance reimbursement approval in 2024, Sky Labs’ Cart BP pro has been adopted by approximately 1,700 hospitals and clinics nationwide.

With the CE-MDR certification now secured, Sky Labs plans to expand beyond its domestic market into Europe and other global regions. Europe, with a population of around 520 million, represents a significantly larger market with rising demand for chronic disease management solutions, particularly for hypertension.