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Imricor Advances FDA Approval with Third PMA Module Submission
8:55am on Thursday 11th of June, 2026 AEST
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Healthcare
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Imricor Advances FDA Approval with Third PMA Module Submission
8:55am on Thursday 11th of June, 2026 AEST
Key Points
Third PMA module covers non-clinical bench testing
Submission includes Vision-MR Ablation Catheter 2.0 and related devices
Final clinical module pending from VISABL-AFL trial data
Part of modular FDA review process to streamline approval
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Imricor Medical Systems (ASX:IMR)
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