Sky Labs的无袖血压环在欧洲获得CE-MDR的销售许可。
Sky Labs' cuffless blood pressure ring gains CE-MDR approval for sale in Europe.
Sky Labs是韩国的保健启动单位, 已经获得CE-MDR认证, 以获得环形无手铐血压监测仪(CART PLATFORM),
Sky Labs, a South Korean healthcare startup, has received CE-MDR certification for its ring-shaped, cuffless blood pressure monitor, the CART PLATFORM, enabling its entry into the European market.
该设备使用光膜摄影传感器进行连续24小时监测,并将数据传送给移动应用程序和医生的网络浏览器。
The device uses photoplethysmography sensors to provide continuous 24-hour monitoring and transmits data to a mobile app and web viewer for doctors.
韩国自2024年批准 保险覆盖, 已在1700个诊所使用。
Approved in South Korea since 2024 with insurance coverage, it's already used in about 1,700 clinics.
认证支持向欧洲和标准得到承认的其他区域扩展,反映出全球对该技术的信心不断增强。
The certification supports expansion into Europe and other regions where the standard is recognized, reflecting growing global confidence in the technology.