Ring-type Blood Pressure Monitor 'CART' Completes UK MHRA Medical Device Approval, Establishing Foundation for Entry into the UK Following Europe
- Successfully navigates UK regulatory hurdles following CE-MDR certification
- Demonstrates global competitiveness as the world's only cuffless ring-type blood pressure monitor
SEOUL, South Korea, May 15, 2026 /PRNewswire/ -- 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 authorization 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 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." 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."
About Sky Labs https://skylabs.io/en/
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.
Media Inquiries
Inok Jung [email protected]
Bomi Lee [email protected]
Photo - https://mma.prnewswire.com/media/2980830/image1.jpg
Logo - https://mma.prnewswire.com/media/2765675/5972290/Sky_Labs_Logo.jpg
Artikel teilen