#South Korea #Seoul #Sky Labs #blood pressure monitor #CART Platform

Sky Labs' CART PLATFORM Receives CE-MDR Certification

In a significant milestone for healthcare technology, Sky Labs, led by CEO Jack Byunghwan Lee, announced on January 8, 2026, that its innovative ring-shaped blood pressure monitor, named the 'CART PLATFORM', has achieved CE-MDR certification from the European Union. This important certification validates Sky Labs' commitment to delivering advanced health monitoring technology, allowing for broader access to global healthcare markets.

The CART PLATFORM is a state-of-the-art medical device designed with photoplethysmography (PPG) sensors. This technology enables the continuous monitoring of vital signs, focusing primarily on blood pressure. The data collected by the device is transmitted to a mobile application for patient use, while medical professionals can access this information through a web-based viewer. This innovative method is set to revolutionize traditional blood pressure monitoring techniques, which often rely on cumbersome cuff-based systems.

Patients wearing the CART PLATFORM will benefit from its ability to streamline the monitoring process, offering ease of use and enhanced management of blood pressure. The efficacy of this device has already been proven in clinical settings across South Korea, where the CART BP pro has been utilized in around 1,700 hospitals and clinics since it became reimbursable in 2024.

With this CE-MDR certification under its belt, Sky Labs aims to expand from its domestic market in South Korea to European and global markets. Europe, with a population of approximately 520 million, represents a massive opportunity, significantly larger than the South Korean market. Observers are noting an increasing demand for effective treatments for chronic conditions like hypertension, making this a vital time for the introduction of new solutions.

The CE-MDR certification is a critical benchmark in the medical device landscape, not only in Europe but also as a guideline for numerous regions worldwide, including the Middle East, Southeast Asia, and South America. CEO Jack Byunghwan Lee emphasized, "The award of CE-MDR certification is not merely a technical validation; it represents global trust earned through compliance with stringent European medical market regulations. With our unparalleled technology for cuff-free blood pressure monitoring, we are committed to extending our footprint in the global healthcare market."

Founded in September 2015, Sky Labs is at the forefront of healthcare innovation with its development of CART (Cardio Tracker), a ring-shaped device designed to monitor patient vitals by capturing heart signals through optical sensors. The subsequent creation of the CART BP emphasizes the company’s goal of providing continuous, cuff-free blood pressure readings, thus improving the quality of life for hypertension patients.

Supporting its domestic strategy, Sky Labs has recently signed an exclusive distribution agreement with South Korea's Daewoong Pharmaceutical for the CART BP device, further reinforcing its ambitions to reach hospitals, clinics, and individual consumers nationwide. The future looks promising for Sky Labs as it navigates the complexities of international markets, bringing sophisticated tech solutions to patients in need.

For media inquiries, please contact:
Inok Jung: [email protected]
Bomi Lee: [email protected]