CathVision Gets FDA Clearance for Its ECGenius Cardiac Recording Technology

Denmark-based CathVision has received the FDA’s 510(k) clearance for its ECGenius EP (electrophysiology) recording system that delivers high-fidelity, low-noise cardiac electrograms.

The system is designed to help electrophysiologists improve the diagnosis and treatment of complex atrial arrhythmias, including atrial fibrillation. It can also be used to guide ablation therapy, the company said.

ECGenius received funding from the European Union’s Horizon 2020 research and innovation program, which is designed to foster product development in the EU. Now known as Horizon Europe, the program has a budget of $99 billion.

The ECGenius EP system, which is now available in the U.S., is not yet approved for sale in the EU.