SkyLabs cuffless blood pressure ring development

A clinical study conducted by Korea University Anam Hospital has indicated that SkyLabs’ cuffless blood pressure ring, ‘CART’, can improve hypertension control. In a six-month study of 246 patients, those using the device to provide 24-hour data achieved a target blood pressure attainment rate of 65.8%, significantly higher than the 36.3% rate in the standard care control group.

Following these results, SkyLabs announced plans to commercialize its next-generation ring, which aims to eliminate manual calibration by using AI algorithms and photoplethysmography to analyze blood flow. The company is launching a four-year ‘Cuffless Study’ with the Korean Society of Hypertension to compare the device against traditional cuff-based measurements regarding cerebrovascular and cardiovascular disease incidence.

On a global scale, SkyLabs has obtained CE MDR certification for Europe and is seeking entry into the UK’s National Health Service. The company is also targeting U.S. FDA De Novo approval by the fourth quarter of 2027, with a goal of full U.S. commercialization by 2028.