Sky Labs said that CART-ⅠPlus, its ring-type heart rhythm monitoring device, has received approval from the Ministry of Food and Drug Safety to measure blood pressure, too.

The Ministry of Food and Drug Safety has approved the blood pressure measurement function of Sky Labs' CART-ⅠPlus, a ring-type heart rhythm monitoring device.
The Ministry of Food and Drug Safety has approved the blood pressure measurement function of Sky Labs' CART-ⅠPlus, a ring-type heart rhythm monitoring device.

According to the company, CART-ⅠPlus boasts superior convenience by measuring blood pressure using optical capillary pulse waves in a cuffless method rather than a cuff, which compresses the forearm to measure blood pressure.

Since the device comes out as a ring, the company stressed that it could be worn on the finger and monitored continuously for 24 hours without any follow-up measures, greatly improving the inconvenience of existing blood pressure monitors.

The company stressed that the device provides various blood pressure data that have been difficult to accurately determine, such as nighttime blood pressure, morning hypertension, and blood pressure variability.

It also enables medication dose adjustment with blood pressure statistics data, which can make a positive change in patient treatment, and is effective for tracking lifestyle improvement changes such as sleep, stress management, exercise, alcohol consumption, and response to blood pressure medication.

“Using the MFDS approval as a stepping stone, we are accelerating our progress receiving toward U.S. Food and Drug Administration and European CE approval for CART-ⅠPlus’ blood pressure measurement function,” Sky Labs CEO Lee Byung-hwan said.

The approval will further accelerate the company’s global expansion plan to transform the lives of out-of-hospital patients by providing effective and easy treatment and management of hypertension in everyday life, as well as expanding the scope of management to include nocturnal hypertension during sleep, which has become increasingly important in recent years, Lee added.

Meanwhile, the Korea Health Insurance Review and Assessment Service approved reimbursement for CART-ⅠPlus as an intermittent electrocardiogram in June of last year.

The device, priced at 470,000 won ($360), is being sold through Chong Kun Dang in Korea.

 

 

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