#South Korea #Seoul #Sky Labs #CE-MDR #CART Platform

Sky Labs Achieves CE-MDR Certification for CART PLATFORM

Sky Labs, led by CEO Jack Byunghwan Lee, has made significant strides in the medical technology field by securing CE-MDR certification for its innovative blood pressure monitoring device, known as the "CART PLATFORM." This achievement, announced on January 8, 2026, marks a pivotal moment for the company as it positions itself for a more robust presence in the global healthcare market.

The CART PLATFORM is designed as a ring-type blood pressure monitor that utilizes advanced photoplethysmography (PPG) sensors to accurately monitor vital signs. Beyond merely tracking blood pressure, the device also effectively detects irregular pulses, making it a versatile tool for comprehensive patient monitoring. When worn by a patient, the device captures vital signs and transmits the data through a mobile application. Medical professionals can then review this information using a web viewer, streamlining the monitoring process compared to traditional methods that often rely on uncomfortable blood pressure cuffs.

Since its introduction in South Korea, where it has been adopted by approximately 1,700 hospitals and clinics after being eligible for insurance reimbursement in 2024, the CART PLATFORM has shown great potential in transforming how blood pressure is monitored. Patients have expressed appreciation for the comfort provided by this cuffless solution, which is critical for individuals needing around-the-clock monitoring.

With the CE-MDR certification under its belt, Sky Labs is now set to expand both its operations and market reach beyond South Korea into the European healthcare landscape. The European market, representing a population of around 520 million, offers a substantial opportunity since the demand for chronic disease management, particularly hypertension, continues to grow. The CE-MDR certification is not just a technical approval; it acts as a vital gateway for medical device regulation in various regions worldwide, including Southeast Asia, the Middle East, and South America.

Jack Byunghwan Lee, CEO of Sky Labs, emphasized the importance of this certification by stating, "Achieving CE-MDR certification signifies our compliance with stringent European medical standards, thereby winning global trust. Our unmatched technology, which facilitates comfortable, cuffless blood pressure monitoring, will continue to drive our global healthcare expansion."

Sky Labs, founded in September 2015, is a trailblazer in health technology, having developed the CART (Cardio Tracker) system, initially aimed at monitoring heart-related diseases through optical sensor signals. The firm subsequently innovated the CART BP, a cuffless blood pressure monitoring solution, which serves not merely as a medical device but as a potential life-enhancing tool for those suffering from hypertension.

The company is strategically positioned to embark on its national distribution journey, having signed an exclusive agreement with Daewoong Pharmaceutical to deliver CART BP across hospitals, clinics, and the general public in South Korea. This partnership not only solidifies the product's local presence but also sets the stage for successful international ventures.

As Sky Labs makes its way into the European market, there is anticipation surrounding the potential impact the CART PLATFORM could have on improving patient outcomes through enhanced comfort and more effective health monitoring practices. By combining cutting-edge technology with a commitment to patient care, Sky Labs is set to lead the charge in the next wave of medical monitoring solutions worldwide.