Imricor's FDA Approval for NorthStar 3D Mapping System

Imricor Medical Systems, Inc. (ASX: $IMR) has announced that the US Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) supplement to include Imricor's NorthStar 3D mapping system in the VISABL-AFL pivotal clinical trial. This approval is a significant step towards the commercialization of NorthStar in the United States and is intended to support FDA approval of Imricor's products in the country.

Executive Commentary on FDA Approval

IDE approval of NorthStar is a significant step forward toward NorthStar's commercialization in the United States. This IDE supplement allows the NorthStar 3D mapping system to be used by clinical sites participating in the VISABL-AFL trial, allowing us to gather valuable user data on the system, which will help support its eventual FDA clearance via the 510(k) process. In addition, sites participating in the trial will have the benefit of NorthStar's capabilities for their procedures.

Summary of FDA Approval and Outlook

The FDA approval of Imricor's NorthStar 3D mapping system for use in the VISABL-AFL clinical trial marks a significant milestone in the company's efforts to expand its product offerings in the United States. This approval is expected to facilitate the gathering of valuable user data on the system, supporting its eventual FDA clearance. Imricor's Chair and CEO, Steve Wedan, emphasized the importance of this approval in advancing NorthStar's commercialization. Looking ahead, Imricor aims to leverage the data gathered from the trial to further support the clearance process and enhance the capabilities of its products for cardiac ablation procedures.