[CoreMap in GlobeNewswire] CoreMap, Inc. Receives U.S. FDA Investigational Device Exemption (IDE) Approval for INvENI Map-Guided AF Ablation Study
BURLINGTON, Mass., May 28, 2025 (GLOBE NEWSWIRE) — CoreMap today announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to extend the INvENI clinical study into the U.S. This study is designed to evaluate the safety and effectiveness of the proprietary CoreMap™ Endocardial Electrophysiology (EP) Mapping System in patients with persistent Atrial Fibrillation (AF) and long-standing persistent AF. To date, CoreMap has demonstrated safety and acute effectiveness of its EP Mapping system in over 50 patients. Read...
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