South Korean health AI and medical device startups remain determined to prioritise Europe and the United States for global expansion despite tightening regulatory and reimbursement barriers.
In recent years, major overseas markets have imposed increasingly stringent requirements for market entry, with regulators and payers demanding extensive real-world evidence, reproducibility across clinical workflows, and comparative validation against gold standard methods before new technologies are accepted into routine care.
Yet Korean companies such as Sky Labs, a developer of a ring-type blood pressure monitoring platform, continue to push into these highly competitive and regulated markets, betting that their domestic clinical track records can translate into international credibility.
Earlier this month, Sky Labs announced that its CART PLATFORM had obtained European Union Medical Device Regulation (CE-MDR) certification for its ring-type device, along with a companion mobile application, backend server, and web-based viewer used by medical professionals.
Since securing local insurance reimbursement in 2024, the CART BP Pro has been prescribed across roughly 1,700 hospitals and clinics in Korea, a track record the company now aims to leverage as it expands overseas.
Mobihealth News
caught up with Sky Labs CEO Jack Byunghwan Lee to discuss why Europe and the US remain priority targets for Korean healthcare startups, how the company assessed its readiness to go global, and what international health systems are willing to pay for as regulatory and reimbursement scrutiny intensifies.
Q. What does securing CE-MDR clearance for the CART PLATFORM change concretely for Sky Labs as a business (beyond market access), and how does this milestone reshape your regulatory, commercial, or partnership strategy compared with operating solely under Korea's reimbursement-backed system?
A.
CE-MDR certification signifies more than just entering the European market; it is a crucial milestone as Sky Labs is transitioning its business structure and growth strategy to become a global medical device and digital health platform company.
Specifically, Sky Labs is meticulously reviewing each country's healthcare system and reimbursement frameworks by leveraging clinical evidence and real-world data accumulated through patient prescriptions and usage within Korea's National Health Insurance reimbursement system.
Sky Labs plans to explore commercialisation strategies tailored to each country's regulatory environment, aiming to reduce patient burden while enabling more convenient product use. To this end, we are discussing various collaboration options with global partners, including local companies.
Q. How did Sky Labs determine that it was ready to move beyond Korea and pursue CE-MDR clearance at this stage? What internal benchmarks, clinical evidence, regulatory preparation, or commercial signals convinced the company that it was prepared to compete in international markets? Any update on the ongoing regulatory filings, say, in the United States and other countries/regions like Japan, the Middle East, and Southeast Asia?
A.
The decisive factor was the simultaneous confirmation that our platform is functioning sufficiently in actual clinical settings across clinical, regulatory, and commercial aspects, having moved beyond the technology validation stage.
Internally, we utilised our experience with physician-led prescriptions and the successful expansion within the institutional framework of the Korean market as a critical benchmark. The data and clinical experience accumulated through actual patient care under the national health insurance reimbursement system served as a powerful signal, proving the reproducibility and reliability of our technology in real-world medical environments rather than just controlled clinical research settings.
From a clinical perspective, we determined that we had accumulated sufficient evidence to address the core requirements of international regulatory authorities. This includes not only individual study results but also comparative studies with traditional blood pressure measurement methods, consistency in repeated measurements, and demonstrated utility within actual clinical workflows.
With the CE-MDR certification, we are now accelerating our global business expansion, including the European market. For the US [FDA approval], we are reviewing clinical strategies and regulatory pathways aligned with the US regulatory framework and proceeding with phased preparations. For Japan, we are preparing market entry based on local partnerships. For the Middle East and other countries, given the varying national regulatory requirements and payment structures, we are concurrently reviewing regulatory approvals and commercialisation models with local partners.
Q. Cuffless blood pressure monitoring via smart rings has long been discussed but cautiously adopted. What are you seeing in terms of real clinical demand, payer interest, and physician confidence internationally, and which use cases (e.g., hypertension management, long-term monitoring, population health) are gaining traction fastest outside Korea?
A.
Despite long discussions about cuffless blood pressure measurement technology, its adoption has been cautious because overseas markets also have extremely stringent verification standards for clinical efficacy and medical reliability. This aspect is not significantly different from Korea.
Korea is a conservative market with very high entry barriers due to its single public health insurance system, and medical professionals also tend not to prescribe devices unless their clinical efficacy is institutionally verified. Sky Labs' cuffless ring-type blood pressure monitor, CART, has secured health insurance coverage within this environment and been adopted by over 1,700 hospitals and clinics in Korea within just one year of its launch. This achievement demonstrates that CART’s technical and clinical validity has been proven in actual medical settings. The primary driver behind this is that CART has secured global-standard reliability through comparative clinical trials against conventional methods, including auscultation, invasive arterial lines (A-line), and cuff-based ambulatory blood pressure monitoring (ABPM).
At the European Society of Cardiology Congress 2025, research results were presented showing that the CART satisfied the requirements for awake/asleep test and device position test, which are considered the most difficult to validate among six validation criteria for cuffless blood pressure monitors established by the European Society of Hypertension (ESH) in 2023. This marks CART as the only wearable blood pressure monitor globally to receive recognition for its clinical validity at the international level.
Q. As Sky Labs expands globally, how do you position a CE-MDR-marked, medical-grade smart ring against consumer wearables, hospital-grade ambulatory monitors, and emerging AI-driven remote monitoring platforms?
A.
Medical professionals have long felt burdened by recommending 24-hour ABPM to patients. Existing cuff-type devices caused significant discomfort due to noise, pain from strong compression, and sleep disruption, severely disrupting patients' daily lives. This led to high patient resistance, and some even abandoned the monitoring midway.
Another challenge was the difficulty of re-measurement to ensure data reproducibility. When blood pressure variability was observed, additional monitoring was needed for accurate diagnosis. However, it was challenging to persuade patients complaining of discomfort to undergo repeat measurements. Particularly, when confirming stabilisation after adjusting medication for blood pressure variability, healthcare providers faced limitations in determining optimal treatment directions, such as appropriate drug prescriptions, if patients refused remeasurement.
However, the ring-type blood pressure monitor, CART, has resolved these challenges for medical professionals. Wearing the ring causes no discomfort in daily life while enabling 24-hour measurement, eliminating patient resistance and reducing complaints. The comfort of wearing the device allows for measurement over several days. Consequently, medical staff can now reliably obtain data on the effects of medication tailored to blood pressure variability, enabling them to propose optimal treatment plans.
In June last year, US 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 ageing population, thereby enhancing the long-term sustainability of national healthcare finances.
This is not solely an American issue. Globally, ageing populations demand improvements in national healthcare finances.
Sky Labs' CART analyses 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 recognised in actual clinical settings, beyond merely providing reference values.
Therefore, through our unique blood pressure monitoring technology, we can effectively prevent hypertension from progressing into severe disease and contribute to enhancing the sustainability and efficiency of future global healthcare systems.
Q. What is the competitive edge you believe international health systems will pay for?
A.
The core criteria for international healthcare systems to invest in a solution are clinical reliability, field applicability, and reproducibility within reimbursement structures. Sky Labs’ competitive advantage lies in its ability to simultaneously satisfy these three requirements.
First, Sky Labs' cuffless ring-type blood pressure monitoring solution has secured national health insurance reimbursement in Korea.
Second, the application of Korea's National Health Insurance coverage signifies more than just regulatory certification; it means that the clinical efficacy and practical utility in a medical setting have been evaluated and verified through formal institutional procedures. In other words, Sky Labs has secured evidence and operational systems not just to become a certified device, but to establish a level of justification for payment from the insurer's perspective.
Third, in terms of clinical performance, Sky Labs has accumulated results that healthcare professionals can trust through comparative trials against gold standard benchmarks such as auscultatory methods, A-line, and cuff-based ABPM. This evidence serves as the foundation for building trust with international clinicians and payers as we expand globally.
Ultimately, Sky Labs' differentiator lies in simultaneously demonstrating clinical trustworthiness and field scalability for its highly user-friendly cuffless ring-type blood pressure monitor.
Q. Many Korean digital health and medical device startups are now targeting Europe and the US. Why do you think these markets have become such priorities for Korean companies, and will Korean startups continue their aggressive global expansion this 2026?
A.
Other Korean companies, including Sky Labs, are expected to target the European and American markets. The US and European populations are about 340 million and 520 million, respectively, which are about six times and 10 times larger than Korea's. Accordingly, many companies are anticipated to actively pursue entry into these regions.
Furthermore, the medical device markets in the US and Europe are well-known for their high barriers to entry. Achieving success in these two markets is considered a highly effective strategy for solidifying a company's status as a global player.
Q. How does Sky Labs balance the push for global scale with practical concerns like profitability, reimbursement pathways, and meeting real clinical demand rather than chasing regulatory milestones alone?
A.
Leveraging the accessibility provided by Korea's health insurance reimbursement system, CART was adopted by approximately 1,700 hospitals and clinics within just one year – a significant achievement in the conservative Korean medical market. Notably, as of December 2025, it reached a cumulative total of approximately 180,000 prescriptions and uses, demonstrating its rapid integration into actual clinical practice.
This achievement is significant as it represents a proven case where clinical utility and operational viability have been verified through repeated use in real-world settings. This large-scale real-world usage data and validation system will serve as a crucial reference for securing medical professionals' trust and establishing a market presence during overseas expansion.
Building on this domestic foundation, we plan to strategically create global demand by proactively generating local pilot studies and bridge evidence tailored to each target country's specific clinical guidelines, reimbursement/coding structures, and healthcare delivery systems.
_
Lee's responses have been edited for brevity
.
