Sky Labs Earns U.K. MHRA Authorization for its Ring-Type Blood Pressure Monitor

The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing approval to CART, Sky Labs’ ring-type blood pressure monitoring platform.

The MHRA is a government agency regulating the safety, quality, and efficacy of all medicines and medical devices. Following its European Medical Device Regulation (CE-MDR) certification earlier this year, Sky Labs has now solidified its foundation for entering the U.K. market by completing the MHRA registration and approval process.

The CART platform integrates a ring-type wearable device, a mobile app, a server, and a web viewer for medical professionals. With the entire platform—from hardware to software—having passed certification, Sky Labs plans to launch full-scale sales through prescriptions at U.K. pharmacies, hospitals, and clinics.

Sky Labs’ ring-type wearable blood pressure monitor, CART BP pro, has already established a dominant presence in its home market. In addition to approval from the Ministry of Food and Drug Safety (MFDS)—South Korea’s national regulatory authority equivalent to the U.S. Food and Drug Administration—the device has been integrated into clinical practice at approximately 1,800 hospitals and clinics nationwide since obtaining medical service reimbursement in 2024.

“In a system centered on cuff-type blood pressure monitors that has been maintained for hundreds of years, the fact that the world’s only cuffless ring-type blood pressure monitor has received medical device authorization from international regulatory agencies proves that Sky Labs’ technology and clinical maturity have been recognized by global standards,” Sky Labs CEO Jack Byunghwan Lee said. “This shows that a new paradigm in blood pressure management, which simultaneously satisfies the clinical efficiency of medical staff and the measurement convenience of patients, is becoming a reality.”

Founded in September 2015, Sky Labs is a healthcare company that develops and operates CART, a ring-type medical device and platform for monitoring chronic disease patients. Since the first CART was developed in 2020 for atrial fibrillation monitoring using cardiac signals from optical sensors, the company has expanded its capabilities. In 2023, Sky Labs received medical device approval for CART BP pro, a ring-type monitor designed for 24-hour blood pressure measurement. In 2024, CART BP pro was recognized by the Health Insurance Review and Assessment Service (HIRA) under the existing medical procedure of “24-hour ambulatory blood pressure monitoring” (reimbursement code E6547), and is currently being prescribed in hospitals and clinics across Korea. Furthermore, in September 2025, the company launched CART BP, a consumer-grade ring-type blood pressure monitor, which is available through its official online store and various other online channels.