Sky Labs cuffless blood pressure monitor gains recognition

/ in Product News

Sky Labs, a South Korean digital healthcare startup, has gained significant international recognition for its pioneering ring-type cuffless blood pressure monitoring technology following presentations at the European Society of Hypertension (ESH) 2025 conference in Milan, Italy.

The company’s CART BP device represents the world’s first ring-shaped cuffless blood pressure monitor capable of 24-hour continuous monitoring, addressing key limitations of traditional cuff-based ambulatory blood pressure monitoring (ABPM) systems.

ESH 2025 symposium highlights cuffless technology potential

During a symposium titled “Breaking Boundaries in Hypertension Care: A New Era with Cuffless Blood Pressure Monitoring” on 25 May, leading experts emphasised the clinical significance of Sky Labs’ technology. Professor George Stergiou from the University of Athens, Greece, and Professor Hae-Young Lee from Seoul National University Hospital, South Korea, delivered presentations focusing on the current landscape and future prospects of cuffless blood pressure monitoring.

Both experts highlighted that Sky Labs is currently collecting the world’s largest dataset of 24-hour blood pressure measurements using cuffless methodology as a potential alternative to conventional ABPM.

Professor Lee remarked: “Cuffless blood pressure monitors are considered a meaningful innovation beyond convenience. Sky Labs’ ring-type device enables 24-hour monitoring without interfering with daily activities, addressing limitations of conventional cuff-based monitors, such as discomfort and restricted measurement frequency. Its ability to provide continuous, especially nocturnal, readings may support a new approach to hypertension management.”

Clinical validation and regulatory approval

The CART BP device has undergone rigorous clinical validation through studies conducted at Samsung Medical Center’s Cardiology Department. Research involving 89 adults (average age 40) demonstrated remarkable accuracy compared to traditional auscultatory methods, with mean differences of just 0.16 mmHg for systolic and 0.07 mmHg for diastolic readings. The correlation coefficients for systolic and diastolic pressure were 0.94 and 0.95 respectively, indicating strong agreement between measurement methods.

In March 2023, CART BP received medical device approval from South Korea’s Ministry of Food and Drug Safety (MFDS). The device gained significant commercial traction following its inclusion under reimbursement code E6547 from the Health Insurance Review and Assessment Service (HIRA) in June 2024, making it eligible for prescription in South Korean healthcare facilities.

Advanced AI-driven technology

Sky Labs has developed sophisticated algorithms for blood pressure measurement using photoplethysmogram (PPG) signals, leveraging 320,535 samples from 4,185 arterial pressure readings. The technology maintains precise readings even under challenging conditions, including significant blood pressure fluctuations, by segmenting PPG signals into specific intervals.

The validation of this innovative algorithm received recognition through publication in Scientific Reports, a leading Nature journal, in May 2023.

Market expansion and consumer applications

Building on clinical success, Sky Labs plans to launch CART BP, a consumer-focused version of the ring-type monitor, in September 2025. Professor Alta Schutte, speaking at a separate ESH session on unresolved challenges in blood pressure measurement, emphasised that cuffless monitors have strong potential in both clinical and consumer markets due to their ability to address persistent issues with cuff-based devices, including discomfort, infrequent measurements, and poor patient adherence.

Regulatory status: MFDS approved (South Korea); FDA and CE mark applications in progress

• For more information, visit: https://www.skylabs.io/en