Approval Lag for Ablation Catheters: A Comparative Analysis of Regulatory Timelines in the European Union, United States, and Japan.

Abstract

Approval timelines for ablation catheters differ across major markets, potentially delaying clinical access. This study aimed to quantify approval lags for contemporary ablation catheters across the EU, the US, and Japan. We retrospectively identified therapeutic ablation catheters with documented approval dates in the European Union, the United States, and Japan using data from PMDA, FDA, and European notified-body/manufacturer sources. Non-therapeutic accessories were excluded. Month-level app