As cuffless blood pressure monitoring moves from promise to clinical reality, South Korea–based Sky Labs is emerging as one of the few companies globally to translate wearable innovation into validated medical practice. With its CART PLATFORM becoming the only wearable blood pressure system to secure CE-MDR certification across hardware, software, and data infrastructure, the company is redefining how hypertension is diagnosed and managed in daily life.
Adopted by more than 1,700 hospitals and clinics in Korea and backed by rigorous international clinical standards, CART is positioning cuffless monitoring as a credible alternative to traditional 24-hour ambulatory devices. In this interview, Jack Lee, CEO of Sky Labs, discusses the technical and regulatory journey behind CE-MDR approval, the clinical impact of large-scale deployment, the role of AI in preventive hypertension care, and the company’s expansion strategy for Europe’s rapidly evolving digital health market.
The CE-MDR certification is one of the most stringent regulatory benchmarks globally. What were the key technical and clinical challenges Sky Labs overcame to secure approval for the entire CART PLATFORM ecosystem, including the software and data infrastructure?
At the 2025 Autumn Scientific Meeting of the Korean Society of Hypertension, the CART garnered attention as the only device to meet all three internationally recognized core clinical standards: △24-hour Ambulatory Blood Pressure Monitoring (ABPM), △Invasive Arterial Line (A-line), and △Auscultation method.
Furthermore, CART has already met three critical criteria out of the six items in the European Society of Hypertension (ESH)’s 2023 cuffless guidelines: ▲Static Test (absolute BP accuracy), ▲Device Position Test and ▲Awake·Asleep Test. This makes it the only wearable BP monitor to have its clinical validity recognized at the global level.
Awake·Asleep Test: In a comparative validation with cuff-based 24-hour ABPM, CART met the ESH criteria: the mean difference in daytime and nighttime systolic/diastolic BP changes was within 5 mmHg, the standard deviation was within 8 mmHg, and the correlation coefficient for BP changes was 0.70 or higher. These results demonstrate that CART can validly track blood pressure fluctuations during both daytime and nighttime.
Device Position Test: Conventional cuff-type blood pressure monitors require the arm to be positioned at heart level for accurate measurements. Sky Labs demonstrated that its PPG (photoplethysmography) sensor and advanced algorithms maintain high accuracy even in everyday situations where arm height varies.
As CART PLATFORM replaces or complements traditional 24-hour cuff-based monitoring, how does your PPG-based approach improve measurement accuracy and patient adherence in daily-life settings?
Traditional cuff-based monitors cause noise and pain due to strong compression of the arm, which often degrades sleep quality and limits the collection of accurate nighttime data. CART, Sky Labs' PPG-based ring-type monitor, eliminates these discomforts. Patients can monitor their blood pressure without any sensation of a foreign object during daily life or sleep, leading to significantly improved patient adherence.
Normal blood pressure is typically 10-20% lower at night than during the day, but research shows that higher blood pressure at night increases the risk of dementia by 64%, which is why night blood pressure management is so important. CART can accurately measure blood pressure patterns at night without disturbing sleep.
The ‘Morning Surge’ phenomenon, where blood pressure rises sharply immediately after waking, also requires careful attention. This is because if morning blood pressure is 20 mmHg higher than the average blood pressure during sleep, it significantly increases the risk of fatal cardiovascular diseases such as stroke or myocardial infarction. CART plays a crucial role in the proactive prevention and management of severe diseases by monitoring blood pressure from before waking up until after.
CART BP pro has been adopted by approximately 1,700 hospitals and clinics in Korea since receiving insurance reimbursement in 2024. What clinical outcomes or operational benefits have been most notable from this large-scale deployment?
The most remarkable change is the improvement in ‘prescription adherence’ and ‘continuity of care’. Previously, medical professionals felt burdened when prescribing 24-hour ABPM, using traditional cuff-based BP monitor because patients often complained of pain, noise, and sleep disruption, sometimes even abandoning the test midway.
Another challenge was the difficulty of re-measurement to ensure data reproducibility. When BP variability is observed, additional monitoring is essential for an accurate diagnosis, but it was hard to ask patients complaining of discomfort to undergo the test again. Particularly during the process of confirming whether the patient's condition had stabilized after adjusting blood pressure medication due to variability, if the patient refused repeat measurements, medical staff faced limitations in determining the optimal treatment path, such as appropriate medication prescriptions.
The ring-type blood pressure monitor CART has resolved these challenges for clinics and hospitals.
Wearing the ring allows 24-hour measurement without disrupting daily life, eliminating patient reluctance and reducing complaints.
The comfort of wearing the device enables measurement over several days. Consequently, medical staff can now reliably obtain data reflecting the effects of medication even after prescribing drugs tailored to blood pressure variability, allowing them to propose optimal treatment plans.
Furthermore, since the examination can be conducted simply by instructing the patient to wear the ring, without complex equipment setup, operational efficiency has also improved.
With the platform encompassing a mobile app, server, and clinician web viewer, how critical is the integration of software and data analytics in enabling continuous blood pressure management?
The integration of software and data analytics is a core infrastructure that goes beyond simple ‘measurement’ to help deliver optimal care and prescriptions in actual clinical settings. BP data collected via the patient’s mobile app is analyzed on our servers and visualized into intuitive reports for medical professionals. This allows professionals to identify meaningful BP patterns during consultations and make accurate, data-driven treatment decisions.
While the CART PLATFORM has proven its effectiveness primarily in outpatient settings, we are now advancing the system to integrate with Electronic Medical Record (EMR) systems at general hospitals for inpatient care. This will allow medical staff to precisely monitor the BP status of multiple patients within a ward.
This integrated platform will serve as a bridge connecting patients and medical institutions in the upcoming era of telemedicine. Medical professionals will be able to suggest appropriate treatments based on patients' blood pressure data regardless of location, while patients can manage hypertension in their daily lives and proactively prevent related complications.
Europe represents a market more than ten times the size of Korea. How does Sky Labs plan to adapt its go-to-market, clinical partnerships, and reimbursement strategies for European healthcare systems?
We are planning to expand into several countries in Europe, including the UK. Since medical reimbursement systems vary by country, we intend to deploy localized Go-To-Market (GTM) strategies. By meticulously analyzing each nation's system to secure optimal reimbursement, we aim to minimize the financial burden on patients
How do you see cuffless, wearable-based monitoring shaping the future of hypertension management, and what role will AI play in moving toward proactive, preventive care?
Sky Labs' CART analyzes minute vital signs collected via PPG sensors using AI deep learning, measuring and quantifying even subtle blood pressure fluctuations. While the market is flooded with various wellness products, securing credibility as a certified medical device approved through rigorous government licensing is essential to achieve ‘medical value’ recognized in actual clinical settings, beyond merely providing reference values.
In June last year, U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. announced a national campaign to have all Americans wearing wearable devices within four years, defining AI-based wearables as a core solution for chronic disease management. This aligns with public health objectives: proactively managing chronic diseases from early stages to prevent progression to severe conditions amid an aging population, thereby enhancing the long-term sustainability of national healthcare finances.
Ultimately, the core issue is not merely whether AI technology is incorporated, but the accuracy of measurements enabled by AI and the validity of clinical judgments based on them.
From this perspective, the ring-type blood pressure monitor, CART's acquisition of certification from the Korean Ministry of Food and Drug Safety and the European CE-MDR holds significant meaning. It is significant in that it has secured objective reliability for use in actual medical settings, going beyond mere technological implementation.
Sky Labs will continue to leverage its advanced AI technology to effectively prevent hypertension from worsening into severe diseases, and we will contribute to increasing the sustainability and efficiency of the global health care system in the future.
