Sky Labs Achieves CE-MDR Certification for CART Platform, Expanding Global Market Reach

Sky Labs Achieves CE-MDR Certification for CART Platform

On January 8, 2026, Sky Labs, led by CEO Jack Byunghwan Lee, proudly announced that its innovative blood pressure monitoring device, known as the 'CART PLATFORM', has been granted CE-MDR certification by the European Union. This pivotal certification encompasses the entire CART PLATFORM ecosystem, which includes a ring-shaped medical device equipped with photoplethysmography (PPG) sensors along with a mobile app, server, and web viewer designed for healthcare professionals.

The CART PLATFORM is particularly distinguished by its ability to monitor vital signs and detect irregular pulse rates—features that are crucial for effective health management. When patients wear the ring, it unobtrusively gathers essential health data which is then relayed to the patient through the mobile application. Meanwhile, healthcare professionals can access and review this information via a dedicated web interface. This setup aims to replace or supplement traditional cuff-based monitoring methods, enhancing patient comfort while ensuring streamlined blood pressure management.

Sky Labs has already validated the effectiveness of these features in the South Korean medical field. Since receiving reimbursement approval in 2024, the CART BP pro has been utilized in approximately 1,700 hospitals and clinics across Korea.

With the CE-MDR certification now in hand, Sky Labs is set to broaden its business framework, venturing into European and global markets. Europe, with a population of about 520 million, represents a market over ten times larger than South Korea's, boasting an increasing demand for chronic disease management solutions such as hypertension. The CE-MDR certification is notably significant as it not only serves as a key driver for medical device licenses within Europe, but it’s also a critical asset for expanding into various regions globally, including the Middle East, Southeast Asia, and South America.

Jack Byunghwan Lee expressed enthusiasm regarding this milestone, stating, “Obtaining the CE-MDR certification transcends mere technical validation; it signifies that we have gained global trust by adhering to the stringent regulations set forth by the European medical market.” He further emphasized the company’s commitment to expanding its global presence, leveraging its unrivaled technology that facilitates cuff-free blood pressure monitoring in daily life.

Sky Labs, founded in September 2015, has emerged as a leader in the health tech space, focusing on the development of CART (Cardio Tracker) to monitor diseases using cardiac signals collected through optical sensors. The company later innovated the CART BP—a cuff-free ring designed for continuous blood pressure monitoring that provides valuable insights for treatment and significantly improves the quality of life for hypertensive patients.

In addition, Sky Labs has entered into an exclusive national distribution agreement for the CART BP with Daewoong Pharmaceutical in South Korea. The company is gearing up for nationwide sales targeting hospitals, clinics, and general consumers.

For further information about Sky Labs, please visit Sky Labs Website.