The U.S. Food and Drug Administration has given 510(k) marketing clearance to Palo Alto, Calif.-based Topera for its latest 3D mapping system, according to a news release.
Topera's mapping systems help diagnose complex arrhythmias and allows physicians to develop individual treatment plans for patients, according to the news release.
The latest generation of mapping systems to receive FDA 510(k) clearance features almost instant intra-procedural mapping and re-mapping capabilities. The new mapping system also uses color imaging to help identify an electrophysiological process that sustains atrial fibrillation, according to the release.
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