Sky Labs Unveils Ring-Type Cuffless Blood Pressure Monitor CART BP pro for Drug Clinical Trials at Basel Summit
核心洞察
Sky Labs presented its ring-type cuffless blood pressure monitor, CART BP pro (搜索), at the 9th Digital Biomarkers in Clinical Trials Summit in Basel, Switzerland, highlighting its potential for clinical trials and Real-World Evidence data collection.
The device addresses critical limitations of conventional cuff-type 24-hour ABPM devices, which cause sleep disruption in 70.2% of users and a 50.0% failure rate in low-tolerability participants during repeated measurements.
CART BP pro (搜索) is already covered under South Korea's national health insurance and is officially recommended in the revised Korean Guidelines for the Management of Hypertension (搜索).
Sky Labs introduced its ring-type cuffless blood pressure monitor, CART BP pro (搜索), as a potential data platform for drug clinical trials at the 9th Digital Biomarkers in Clinical Trials Summit held in Basel, Switzerland. The announcement, made on July 2, 2026, positions the South Korean healthcare company to become a core partner for global pharmaceutical firms seeking high-quality vital signs data collected with patient consent.
The summit, which convened approximately 350 attendees including representatives from Roche and Novartis, serves as an international forum where multinational pharmaceutical companies, clinical trial experts, and digital healthcare enterprises discuss innovative clinical trial methodologies leveraging wearable devices and digital health technologies. The event's Basel location, home to Roche's global headquarters, underscored its strategic importance.
Addressing Critical Limitations of Conventional ABPM
In its presentation, Sky Labs drew significant attention by detailing the shortcomings of conventional cuff-type 24-hour ambulatory blood pressure monitoring (ABPM) devices, which remain widely used in clinical trials. According to a study by Viera et al. (2011), 70.2% of conventional ABPM users experienced sleep disruption caused by the device awakening them during nighttime measurements. More critically, within the participant group demonstrating low tolerability, the failure rate for collecting adequate 24-hour data increased to 50.0% during repeated measurements.
These arm-constricting cuff-type devices disrupt sleep and cause discomfort, leading to increased dropout rates, higher costs, and delayed clinical timelines. CART BP pro (搜索), by contrast, is worn on the finger and collects blood pressure data during daily activities and sleep without repeated arm constriction, significantly alleviating the measurement burden on subjects and enabling stable, long-term vital signs data collection, including blood pressure and heart rate.
Regulatory Validation and Real-World Applications
CART BP pro (搜索) has already achieved significant regulatory and clinical milestones. The device is currently covered under South Korea's national health insurance system and has been officially recommended for real-world clinical use as a certified cuffless blood pressure monitor in the recently revised Korean Guidelines for the Management of Hypertension (搜索). In 2023, Sky Labs received medical device approval for CART BP pro, and in 2024, the Health Insurance Review and Assessment Service (HIRA) recognized it under the existing medical procedure for 24-hour ambulatory blood pressure monitoring (reimbursement code 'E6547'), enabling its prescription in hospitals and clinics.
Beyond drug development, CART BP pro (搜索) can evaluate therapeutic responses to conventional medications already on the market. By continuously monitoring blood pressure fluctuations based on dosing times, dosages, and lifestyle patterns, the device helps secure Real-World Evidence (RWE) data necessary for evaluating drug efficacy, safety, and patient prognosis.
Strategic Positioning and State-Led Validation
Sky Labs is leveraging the Basel summit to position itself as a core partner in supporting drug clinical trials for global pharmaceutical companies. In South Korea, the platform's utility is already being validated in state-led research through its adoption in a large-scale cohort study managed by the National Institutes of Health (NIH) under the Korea Disease Control and Prevention Agency (KDCA).
"Based on CART BP pro (搜索)'s technology, validated by the Korean Society of Hypertension (搜索) (KSH) guidelines and health insurance coverage, we demonstrated its potential as a high-quality vital sign data platform for clinical trials," said Jack Byunghwan Lee, CEO of Sky Labs. "We intend to expand our clinical trial use cases through strategic collaborations with global pharmaceutical companies."
Founded in September 2015, Sky Labs develops and operates CART, a ring-type medical device and platform for monitoring chronic disease patients. In September 2025, the company also launched CART BP, a consumer-grade ring-type blood pressure monitor available through its official online store and various online channels.