Skylabs Obtains European Medical Device Approval for Ring-Type Wearable Heart Monitoring Device

[Asia Economy Reporter Kim Cheol-hyun] Healthcare startup Skylabs (CEO Byung-hwan Lee) announced on the 12th that its ring-shaped heart monitoring device 'Cart-One' has obtained European medical device certification.

With this European medical device certification, Cart can now be distributed not only in Korea but also in Europe, the United Kingdom, and other countries recognizing this certification. Skylabs' medical wearable device Cart-One uses optical sensors to measure the irregular pulse of atrial fibrillation patients. It can automatically measure continuously 24/7, 365 days a year, simply by wearing it on the finger. Clinical research results showed that Cart-One's atrial fibrillation detection accuracy reaches 99%.

Additionally, Cart-One can add new disease monitoring functions through software updates without hardware changes, planning to expand its functionality to other disease management devices such as arrhythmia, hypertension, heart failure, and respiratory diseases in the future. Skylabs is preparing for U.S. Food and Drug Administration (FDA) approval following Cart-One's domestic and European medical device certifications.

Byung-hwan Lee, CEO of Skylabs, said, "We have received love calls from numerous European hospitals and institutions recognizing the value and necessity of Cart-One," adding, "We will actively pursue global expansion to provide Cart-One to patients worldwide."

This content was produced with the assistance of AI translation services.