Sky Labs (CEO Jack Byunghwan Lee) announced on the 8th that its ring-type blood pressure monitor, 'CART PLATFORM,' recently obtained the European Union's Medical Device Regulation (CE-MDR) certification.
This certification was granted for the entire 'CART PLATFORM,' centred 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.
This is expected to replace or complement the uncomfortable conventional 24-hour cuff-based monitoring methods, 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 utilised in approximately 1,700 hospitals and clinics across Korea.
With this CE-MDR certification as a starting point, Sky Labs plans to expand its domestic-oriented business structure into European and global markets.
Europe, with a population of approximately 520 million, is a market more than ten times larger than Korea, with a steadily increasing demand for managing chronic diseases such as hypertension.
In particular, 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," said Jack Byunghwan Lee, CEO of Sky Labs. "Based on our unrivaled technology that allows cuffless blood pressure monitoring in daily life, we will continue to expand our footprint in the global healthcare market."
