#South Korea #Seoul #Health Tech #Sky Labs #CART Platform

Sky Labs Achieves CE-MDR Certification for CART Platform

Sky Labs, led by CEO Jack Byunghwan Lee, has made headlines by securing the European Union's Medical Device Regulation (CE-MDR) certification for its innovative ring-type blood pressure monitor, known as the CART PLATFORM. This significant milestone was announced on January 8, 2026, and opens doors for the company to expand its presence in the global healthcare market beyond its existing foothold in South Korea.

What is the CART PLATFORM?

The CART PLATFORM is not your average blood pressure monitor. This cutting-edge device utilizes photoplethysmography (PPG) sensors to measure vital signs in a compact ring format. It not only gauges blood pressure but also detects irregular heartbeats, providing a comprehensive view of a patient's cardiovascular health. The data collected through this device is accessible to both patients and healthcare professionals via a mobile app and a web viewer, enhancing the user experience.

Traditional blood pressure monitoring often involves cumbersome cuff-based systems that can be uncomfortable and inconvenient for patients. The CART PLATFORM, however, promises to replace or complement these methods, making blood pressure management more user-friendly. Since it started receiving insurance reimbursement in 2024, the CART BP Pro version has already been adopted in around 1,700 hospitals and clinics throughout Korea, showcasing its effectiveness within the medical field.

Expansion Plans and Market Potential

With the CE-MDR certification in hand, Sky Labs is poised to explore markets outside of Korea, particularly Europe, which is home to approximately 520 million people. This market represents a significant opportunity, being over ten times larger than that of Korea. The growing demand for effective management of chronic conditions like hypertension makes Europe an attractive target for Sky Labs' innovative product.

CEO Jack Byunghwan Lee highlighted the importance of the CE-MDR certification, stating, "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." This certification not only opens doors in Europe but also serves as a benchmark for medical devices in numerous other regions worldwide, including the Middle East, Southeast Asia, and South America.

The Journey of Sky Labs

Founded in September 2015, Sky Labs has been at the forefront of healthcare innovation. Their flagship product, the CART (Cardio Tracker), is a ring-shaped device that allows for detailed disease monitoring through optical sensors. The evolution of this technology led to the creation of the CART BP, which facilitates continuous, cuffless blood pressure monitoring.

In addition to its groundbreaking devices, Sky Labs has established a domestic distribution agreement with South Korea's Daewoong Pharmaceutical, preparing for extensive nationwide sales to hospitals, clinics, and individual consumers. This partnership will further bolster its market presence and drive sales as it expands into new territories.

Conclusion

Sky Labs' achievement in acquiring CE-MDR certification for the CART PLATFORM is a pivotal moment in its mission to enhance global healthcare accessibility. With innovative technology at its helm, the company is not only improving the lives of individuals managing hypertension but is also making strides in establishing itself as a formidable player in the international medical device landscape. As the company looks to the future, it is committed to continuous improvement and expansion, ensuring that advanced healthcare solutions are available to those who need them most.