Acutus Gains 510(k) Clearance, CE Mark for its AcQMap 8 Software

Acutus Medical has received 510(k) clearance from the FDA and a CE mark in Europe for updates to its existing cardiac imaging software, collectively called AcQMap 8.

The Carlsbad, Calif.-based company specializes in improving the way cardiac arrhythmias are diagnosed and treated.

AcQMap 8 includes new mapping algorithms for the company’s AcQMap 3D imaging and mapping system. The new algorithms are designed to quickly highlight regions of interest during the mapping and ablation of complex atrial arrhythmias.