COPENHAGEN, Denmark, Feb. 19, 2025 /PRNewswire/ — CathVision, a medical technology company developing advanced electrophysiology solutions, is proud to announce that it has received CE Mark for its breakthrough product, ECGenius System. This regulatory milestone allows CathVision to market and distribute ECGenius System across the European Economic Area (EEA), bringing state-of-the-art electrophysiology solutions to healthcare providers and patients.
ECGenius System is a cutting-edge medical device designed to provide accurate and real-time electrogram recording. The device leverages advanced signal processing and AI-driven analytics that empower clinicians with actionable insights. The product is already FDA 510(k) cleared
“We are thrilled to achieve CE Mark certification for ECGenius System, which underscores our commitment to delivering high-quality, innovative medical technologies,” say Mads Matthiesen, CEO at CathVision. “This milestone not only validates the safety and efficacy of our device but also represents a significant step toward deploying our product worldwide.”
The CE Mark certification signifies that ECGenius System meets the stringent regulatory requirements of the European Medical Device Regulation (MDR), ensuring compliance with health, safety, and environmental protection standards. With this CE mark certification, CathVision is starting commercialization in the European market in the coming quarters, in addition to its existing customer base in the US.
About CathVision
CathVision is a medical technology company developing advanced electrophysiology solutions, including the innovative ECGenius System and its AI-driven platform, CARDIALYTICS. Our mission is to empower physicians to make informed clinical decisions by providing precise cardiac electrical signals that aid in diagnosing, characterizing, and treating heart rhythm disorders. Founded in 2013, CathVision is headquartered in Denmark, and its U.S. office is in Minnesota.
For more information about the ECGenius System, CARDIALYTICS, or this update, please visit www.cathvision.com or follow us on LinkedIn.
SOURCE CathVision
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