Cathvision has announced the receipt of a CE mark for its breakthrough product, the ECGenius system. According to the company, this regulatory milestone allows Cathvision to market and distribute its ECGenius system across the European Economic Area (EEA), bringing “state-of-the-art” electrophysiology solutions to healthcare providers and patients.
The ECGenius system is a cutting-edge medical device designed to provide accurate and real-time electrogram recording, Cathvision claims, also noting that the device leverages advanced signal processing and artificial intelligence (AI)-driven analytics that empower clinicians with actionable insights. The product is already US Food and Drug Administration (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,” said Mads Matthiesen, chief executive officer (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 the ECGenius system meets the stringent regulatory requirements of the European Medical Device Regulation (MDR), ensuring compliance with health, safety and environmental protection standards, the release continues. With this CE-mark certification, Cathvision is starting commercialisation in the European market in the coming quarters, in addition to providing for its existing customer base in the USA.
