Sky Labs’ ring-type blood pressure monitor ‘CART’ has prepared the footing for its entry into the UK market, following its expansion into Europe.
Sky Labs (CEO Jack Byunghwan Lee) announced on the 15th that its ring-type blood pressure monitoring platform, CART PLATFORM, has officially completed medical device registration and received marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA is a government agency responsible for regulating the safety, quality, and efficacy of all medicines and medical devices. Following its acquisition of the European Medical Device Regulation (CE-MDR) certification in January, Sky Labs has now solidified its foundation for entering the UK market by completing the MHRA registration and approval process.
The CART PLATFORM is a product that integrates ▲a ring-type wearable device ▲a mobile app ▲a server and ▲a web viewer for medical professionals. As the entire platform—from hardware to software—has passed the certification, Sky Labs plans to launch full-scale sales through prescriptions at pharmacies, hospitals, and clinics in the UK market.
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. FDA—the device has been integrated into clinical practice at approximately 1,800 hospitals and clinics nationwide since obtaining medical service reimbursement in 2024. This signifies that the product has proven not only its technological prowess and safety but also its acceptability within the health insurance system.
Jack Byunghwan Lee, CEO of Sky Labs, said, “In a system centred 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 authorisation from international regulatory agencies proves that Sky Labs’ technology and clinical maturity have been recognised by global standards.” He added, “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.”
