Cardiac Image Integration Software Gains FDA Clearance

The FDA cleared St. Jude Medical Inc.’s EnSite Fusion Registration Module, a software designed to help physicians create detailed heart models to facilitate the diagnosis and delivery of therapy for complex abnormal atrial heart rhythms, including Atrial Fibrillation (AF).

The software integrates an EnSite System-created chamber model with a 3D computed tomography (CT) model so that the physician has an improved view of the heart’s anatomy.