Sky Labs is ramping up its efforts to enter the U.S. market by initiating preparations for clinical trials to obtain U.S. Food and Drug Administration (FDA) approval for its innovative ring-shaped blood pressure monitor.
On Thursday, the company announced that it is moving forward with clinical trials for its CART BP pro device. Sky Labs is currently awaiting review by the Institutional Review Board (IRB) and finalizing patient enrollment procedures. The company has set an ambitious target to complete these clinical trials by the first half of 2027.
In a strategic move, Sky Labs engaged in pre-consultation discussions (Q-Submission) with the FDA to fine-tune its clinical design and regulatory approach. The company has also compiled substantial evidence to showcase the product’s performance and clinical efficacy, with findings presented at both domestic and international scientific conferences.
Unlike traditional cuff-based devices that constrict the arm, the CART BP pro is a wearable ring designed for extended blood pressure monitoring. This innovative approach significantly reduces patient discomfort while enabling healthcare providers to conduct more precise analyses of blood pressure fluctuations, including critical nighttime and morning readings.
The CART BP pro has already secured approval from South Korea’s Ministry of Food and Drug Safety. Additionally, it has obtained CE-MDR certification under European medical device regulations and successfully registered with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
Building on its domestic and international regulatory successes and clinical expertise, Sky Labs aims to secure FDA certification. This move is part of the company’s broader strategy to expand its footprint in the global 24-hour ambulatory blood pressure monitoring market. The growing emphasis on nighttime blood pressure as a superior predictor of cardiovascular disease risk compared to daytime measurements underscores the increasing importance of round-the-clock monitoring.
Lee Byung-hwan, Chief Executive Officer (CEO) of Sky Labs, expressed confidence in the company’s progress, stating that they’ve consistently built a strong evidence base demonstrating the product’s performance and clinical value. It’s committed to conducting the FDA approval trials flawlessly, with the goal of establishing ourselves as a trusted leader in ambulatory blood pressure monitoring solutions across the global healthcare landscape.
