Sky Labs, led by CEO Jack Byunghwan Lee, announced on January 8, 2026, that its ring-type blood pressure monitor, known as the CART PLATFORM, has received European Union Medical Device Regulation certification. This approval covers the full system, including the wearable ring device equipped with photoplethysmography sensors, the supporting mobile application, server infrastructure, and the web-based interface for healthcare professionals.
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The CART PLATFORM is designed to monitor blood pressure and other vital signs, including irregular pulse detection, providing patients with real-time feedback through a mobile app while enabling clinicians to track data via a web viewer. By offering a cuffless and wearable alternative, the system aims to replace or complement conventional 24-hour cuff-based monitoring, enhancing patient comfort and streamlining blood pressure management.
The technology has already proven effective in Korea, where the CART BP pro system has been adopted by roughly 1,700 hospitals and clinics following insurance reimbursement approval in 2024. With CE-MDR certification, Sky Labs now plans to expand beyond Korea, entering European and international markets, where the population and demand for chronic disease management, including hypertension, are significantly higher.
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Jack Byunghwan Lee, CEO of Sky Labs, emphasized the global significance of the certification, stating that achieving CE-MDR approval reflects not only compliance with stringent European standards but also global trust in the company’s cuffless blood pressure monitoring technology. He added that Sky Labs intends to leverage its advanced platform to expand its presence in the worldwide healthcare market while continuing to innovate in wearable health monitoring solutions.
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