Sky Labs Secures CE-MDR Certification for CART PLATFORM, Expanding Global Market Reach
On January 8, 2026, Sky Labs, led by CEO Jack Byunghwan Lee, announced that its innovative blood pressure monitoring device, the CART PLATFORM, has achieved CE-MDR certification. This significant milestone not only recognizes the advanced technology of the CART PLATFORM but also positions it for an expansive entry into the global healthcare market.
The CART PLATFORM is designed as a ring-shaped medical device that utilizes Photoplethysmography (PPG) sensors to monitor vital signs. It integrates a mobile application, a server, and a web viewer specifically tailored for healthcare professionals. This amalgamation allows for continuous health monitoring while enhancing patient comfort. The device autonomously records vital data and transmits it to patients via their mobile devices, ensuring real-time accessibility. Healthcare professionals can monitor these metrics through an intuitive online interface, significantly improving the efficiency and comfort of blood pressure management at home.
Previously, patients had to rely on traditional 24-hour monitoring methods, often cumbersome and uncomfortable. The transition to the CART PLATFORM is expected to alleviate these inconveniences, providing a seamless experience for users. The device has already been adopted across approximately 1,700 hospitals and clinics in South Korea since insurance reimbursements began in 2024.
With the CE-MDR certification, Sky Labs is poised to broaden its focus from domestic markets to international territories, particularly Europe, which encompasses around 520 million inhabitants. This market presents a lucrative opportunity with a skyrocketing need for effective treatments for chronic conditions such as hypertension. The CE-MDR not only serves as a key regulatory benchmark within Europe but also facilitates entry into diverse markets across the Middle East, Southeast Asia, and South America.
CEO Jack Byunghwan Lee expressed confidence in the direction of the company's expansion, stating, "The CE-MDR certification is not just a technical affirmation; it symbolizes our commitment to meeting strict regulations and enhancing trust in our solutions globally." He added that the CART PLATFORM's unique capability to measure blood pressure without the need for traditional cuffs will empower Sky Labs to grow its footprint within the global health ecosystem.
Founded in September 2015, Sky Labs has gained recognition as a pioneering startup in the healthcare sector. Its flagship product, CART (Cardio Tracker), is designed to monitor health conditions utilizing heart signals detected by optical sensors. Building upon this innovation, the CART BP emerged as an advanced solution capable of providing continuous blood pressure monitoring for 24 hours, yielding valuable treatment insights while enhancing the quality of life for those afflicted with hypertension.
Looking forward, Sky Labs has forged an exclusive distribution agreement with Daewoong Pharmaceutical to promote the CART BP domestically, paving the way for extensive sales to healthcare institutions, clinics, and consumers.
For media inquiries, please contact:
Inok Jung - [email protected]
Bomi Lee - [email protected]
The CART PLATFORM is designed as a ring-shaped medical device that utilizes Photoplethysmography (PPG) sensors to monitor vital signs. It integrates a mobile application, a server, and a web viewer specifically tailored for healthcare professionals. This amalgamation allows for continuous health monitoring while enhancing patient comfort. The device autonomously records vital data and transmits it to patients via their mobile devices, ensuring real-time accessibility. Healthcare professionals can monitor these metrics through an intuitive online interface, significantly improving the efficiency and comfort of blood pressure management at home.
Previously, patients had to rely on traditional 24-hour monitoring methods, often cumbersome and uncomfortable. The transition to the CART PLATFORM is expected to alleviate these inconveniences, providing a seamless experience for users. The device has already been adopted across approximately 1,700 hospitals and clinics in South Korea since insurance reimbursements began in 2024.
With the CE-MDR certification, Sky Labs is poised to broaden its focus from domestic markets to international territories, particularly Europe, which encompasses around 520 million inhabitants. This market presents a lucrative opportunity with a skyrocketing need for effective treatments for chronic conditions such as hypertension. The CE-MDR not only serves as a key regulatory benchmark within Europe but also facilitates entry into diverse markets across the Middle East, Southeast Asia, and South America.
CEO Jack Byunghwan Lee expressed confidence in the direction of the company's expansion, stating, "The CE-MDR certification is not just a technical affirmation; it symbolizes our commitment to meeting strict regulations and enhancing trust in our solutions globally." He added that the CART PLATFORM's unique capability to measure blood pressure without the need for traditional cuffs will empower Sky Labs to grow its footprint within the global health ecosystem.
Founded in September 2015, Sky Labs has gained recognition as a pioneering startup in the healthcare sector. Its flagship product, CART (Cardio Tracker), is designed to monitor health conditions utilizing heart signals detected by optical sensors. Building upon this innovation, the CART BP emerged as an advanced solution capable of providing continuous blood pressure monitoring for 24 hours, yielding valuable treatment insights while enhancing the quality of life for those afflicted with hypertension.
Looking forward, Sky Labs has forged an exclusive distribution agreement with Daewoong Pharmaceutical to promote the CART BP domestically, paving the way for extensive sales to healthcare institutions, clinics, and consumers.
For media inquiries, please contact:
Inok Jung - [email protected]
Bomi Lee - [email protected]
Topics Health）
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