CE Mark for Acutus Medical’s New 3D Diagnostic Imaging and Mapping Catheter

Acutus Medical has pioneered an innovative approach in the minimally invasive imaging and mapping of cardiac arrhythmias. Now the company has announced the gaining of CE Mark approval for its proprietary real-time 3D diagnostic imaging and dipole density mapping catheter.


Acutus Medical has developed a technology for the treatment of atrial fibrillation (AF), a condition that can lead to a significant decline in the quality of life and increases the risk of serious complications such as stroke or heart failure. Globally, in excess of 10 million people are afflicted with AF.

“The Katheter” is one part of the new stand-alone system being developed by Acutus Medical. The catheter, designed to be inserted into the upper heart chambers, combines 48 ultrasound crystals for creating real-time 3D chamber geometries and 48 novel biopotential electrodes that overlay the charge sources on the geometry to show electrical activation. By understanding the origin of the electrical problems that drive AF, the physician is better able to establish a course of action for its treatment, often including ablation of specific areas of the heart wall.

Company comments

“This is the first step toward commercializing the entire system designed to map the true electrical source of the heart wall’s electrical activation,” Randy Werneth, President and Chief Executive Officer stated. “This first-generation product will be used to collect clinical evidence in support of the anticipated benefits of this novel stand-alone system.”

Source: Acutus Medical, Inc., PR Newswire

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