Sky Labs Secures CE-MDR for 'CART PLATFORM,' Accelerating Its Global Market Entry
- 'CART,' the blood pressure ring, recognized in Europe for its advanced vital sign monitoring technology
- Targeting the global healthcare market beyond Europe through CE-MDR certification
SEOUL, South Korea, Jan. 8, 2026 /PRNewswire/ -- 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,' 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.
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 utilized 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."
About Sky Labs https://skylabs.io/en/
Founded in September 2015, Sky Labs is a leading healthcare startup that has developed CART (Cardio Tracker), a ring-shaped medical device designed for disease monitoring using heart signals collected through optical sensors. Following this, the company developed CART BP, a cuffless, ring-shaped device that enables continuous 24-hour blood pressure monitoring, providing valuable treatment information and making a groundbreaking contribution 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.
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SOURCE Sky Labs
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