Sky Labs, a Korean digital health company, said Thursday that its ring-type blood pressure monitoring platform, CART PLATFORM, received medical device registration and marketing authorization from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA).
CART ring and charging cradle (Courtesy of Sky Labs)
The approval follows the company’s acquisition of European Medical Device Regulation (CE-MDR) certification in January and is expected to support the company’s planned expansion into the U.K. market.
The CART PLATFORM combines a ring-type wearable device, a mobile application, a server and a web viewer for healthcare professionals. Sky Labs said the entire platform, including both hardware and software, was covered under the certification and approval process.
The company said it plans to begin prescription-based sales through pharmacies, hospitals and clinics in the UK.
Sky Labs said its ring-type wearable blood pressure monitor, CART BP pro, has been adopted at about 1,800 hospitals and clinics in Korea since receiving reimbursement status in 2024.
The company added that the device previously received approval from Korea’s Ministry of Food and Drug Safety.
According to Sky Labs, CART BP pro is currently the only cuffless ring-type blood pressure monitor on the market.
Kim Ji-hye
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