Acutus Medical’s Heart Imaging Catheter Cleared by FDA

California-based Acutus Medical has received 510(k) clearance from the FDA for the second generation of its AcQMap catheter, an imaging device that displays 3D maps of the heart and electrical patterns that signal atrial arrythmias.

The catheter uses 48 ultrasound transducers to map the heart’s anatomy and 48 electrodes that display electrical activation patterns along the heart’s inner surface.

The device is used with the company’s AcQMap system, a stand-alone platform that captures the cardiac-imaging information and visually displays the electrical patterns.