South Korean health tech startup Sky Labs has recently obtained the approval of the South Korean Ministry of Food and Drug Safety for the latest blood pressure monitoring feature on its ring-type health monitoring device.
Worn on the finger, CART-I Plus uses PPG and sensor algorithms to measure and monitor blood pressure continuously around the clock. It provides a range of blood pressure data, including nighttime blood pressure, morning blood pressure, and blood pressure variability.
WHY IT MATTERS
According to Sky Labs, the blood pressure monitoring feature on CART supports treatment decision-making and medication dosage adjustment. It also aids in tracking changes in lifestyle habits, such as sleep, stress management, exercise, alcohol consumption and response to blood pressure medication.
“Our goal is to broaden the scope of hypertension management, including nighttime hypertension, which has recently become more important, and to improve the lives of outpatients beyond hospitals with effective and easy hypertension treatment and management,” said Sky Labs CEO Jack Lee.
The company is now working to secure a similar clearance from the United States Food and Drug Administration by the end of the year, as well as a CE MDR marking by 2024.
THE LARGER TREND
This latest MFDS approval came two years since Sky Labs raised $20 million in Series B funding to secure market clearances for CART, as well as to develop more medical devices for monitoring chronic diseases.
The first iteration of Sky Labs’ CART ring, which was cleared by the MFDS in 2020, monitors atrial fibrillation using PPG and ECG signals. Additional capabilities were added to the device, such as measuring oxygen saturation, and most recently, blood pressure.