Sky Labs Achieves CE-MDR Certification for CART PLATFORM, Expanding Global Market Access

Sky Labs Achieves CE-MDR Certification for CART PLATFORM



Sky Labs, under the leadership of CEO Jack Byunghwan Lee, announced on January 8, 2026, that its unique ring-shaped blood pressure monitor, 'CART PLATFORM,' has successfully obtained the CE-MDR certification from the European Union. This significant milestone allows them to expand their reach beyond the European market.

The CART PLATFORM is a sophisticated device that uses photoplethysmography (PPG) sensors to monitor vital signs, including blood pressure, while also offering features such as irregular pulse detection. This advanced technology facilitates comprehensive patient monitoring through a mobile app, with healthcare professionals accessing real-time data via a web viewer.

One of the standout features of the CART PLATFORM is its user-centric design, allowing for blood pressure monitoring without the need for cumbersome cuffs that can cause discomfort to patients. Traditional cuff methods are now being complemented or replaced thanks to this innovative device, improving patient comfort and promoting effective blood pressure management.

This product has already made waves in the South Korean medical sector, proving its reliability since receiving insurance reimbursements in 2024. Approximately 1,700 hospitals and clinics across South Korea are already utilizing 'CART BP pro,' showcasing its positive impact on patient care.

With the CE-MDR certification securely in place, Sky Labs is poised to broaden its business framework and penetrate European and international markets. The European population, estimated to be around 520 million, presents a substantial opportunity, as it provides a market ten times larger than that of South Korea. Moreover, there is a growing demand for effective management of chronic diseases such as hypertension.

Jack Byunghwan Lee commented,

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