The 9 Fr. catheter is designed for use under real-time magnetic resonance imaging (MRI) guidance for the treatment of heart conditions.

The device allows electrophysiologists to visualize cardiac soft tissue with precision and clarity while using what looks, feels, and functions like a traditional ablation catheter, according to Imricor’s website.

It is the company’s first device to receive FDA clearance.

“This is obviously a tremendous milestone for the Imricor team, and I want to acknowledge the outstanding work of the entire team in reaching this achievement,” chair and CEO Steve Wedan said in a news release. “Most of us have worked at companies that have existing medical devices on the U.S. market, and getting a new device on the market is always a big deal. But getting a company’s first device on the U.S. market is an extraordinarily big deal.”