Sky Labs’ ring-type blood pressure monitor, CART PLATFORM, has secured the European Union’s Medical Device Regulation (CE-MDR) certification. The authorization encompasses the entire CART PLATFORM, centered on the ring-type medical device equipped with photoplethysmography (PPG) sensors, and encompassing the mobile app, server, and the web viewer for medical professionals.

With blood pressure measurement at its core, the CART PLATFORM provides various vital sign monitoring functions, including irregular pulse detection. When a patient wears the ring-type medical device equipped with a PPG sensor, vital signs are measured; the collected data is then provided to the patient through a mobile app, while medical staff can monitor it through a web-based viewer.

The CART PLATFORM is expected to replace or complement conventional 24-hour cuff-based monitoring methods, thereby enhancing patient convenience while enabling efficient blood pressure management. These benefits have already been proven in the Korean medical field. Since obtaining insurance reimbursement in 2024, CART BP pro has been used in approximately 1,700 Korean hospitals and clinics.

With this CE-MDR certification as a starting point, Sky Labs plans to expand its domestic-oriented business structure into European and global markets. CE-MDR serves as a crucial benchmark for medical device licensing not only in Europe but also in various regions worldwide, including the Middle East, Southeast Asia, and South America.

“Securing the CE-MDR certification is more than a mere technical validation; it signifies that we have earned global-level trust by meeting the stringent regulations of the European medical market,” Sky Labs CEO Jack Byunghwan Lee said. “Based on our technology that allows cuffless blood pressure monitoring in daily life, we will continue to expand our footprint in the global healthcare market.”

Founded in September 2015, Sky Labs is a healthcare startup that has developed CART (Cardio Tracker), a ring-shaped medical device designed for disease monitoring using heart signals collected through optical sensors. The company also has developed CART BP, a cuffless, ring-shaped device that enables continuous 24-hour blood pressure monitoring, providing valuable treatment information and contributing to improving the quality of life for hypertension patients. Sky Labs has signed an exclusive domestic distribution agreement for CART BP with South Korea’s Daewoong Pharmaceutical and is preparing for nationwide sales to hospitals, clinics, and general consumers.