Sky Labs (CEO Lee Byeong-hwan) announced on the 8th that its ring-type blood pressure monitor 'CART PLATFORM' has obtained CE-MDR (Medical Device Regulation) certification, a European Union (EU) medical device regulation.
This certification was conducted for the entire 'cart platform', including not only ring-type medical devices equipped with photoplethysmography (PPG) sensors, but also mobile apps, servers, and web viewers for medical professionals.
The cart platform provides various biosignal monitoring functions, including blood pressure measurement and irregular heartbeat. When a patient wears a ring-shaped medical device equipped with a PPG sensor, their biosignals are measured. The collected data is provided to the patient via a mobile app, and medical staff can review it via a web-based viewer.
Building on this CE-MDR certification, Skylabs plans to expand its business into the European and global markets. Europe boasts a population of approximately 520 million, and demand for chronic disease management, such as hypertension, is steadily increasing. CE-MDR certification is a key indicator of medical device approval not only in Europe but also in other countries, including the Middle East, Southeast Asia, and South America.
Skylabs CEO Lee Byeong-hwan said, “CE-MDR certification is significant in that it goes beyond technological verification and meets the strict regulations of the European medical market, securing global-level trust.” He added, “We will expand our presence in the global healthcare market based on our unrivaled technology that enables cuff-free blood pressure monitoring.”
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