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Imricor advances US approval path after clean FDA catheter review
9:17am on Thursday 8th of October, 2026 AEDT
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Medical Devices
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Imricor advances US approval path after clean FDA catheter review
9:17am on Thursday 8th of October, 2026 AEDT
Key Points
FDA completes review of Imricor’s largest PMA module
No deficiencies identified for the Vision-MR Ablation Catheter 2.0 or irrigation tubing
One RF-5000 System deficiency relates to outdated third-party operating-system support
Module 3 remains open pending FDA acceptance of Imricor’s response
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