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How Is Imricor Driving Growth Amid US FDA Delays and EU Approvals?
9:20am on Thursday 10th of July, 2025 AEST
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Healthcare
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How Is Imricor Driving Growth Amid US FDA Delays and EU Approvals?
9:20am on Thursday 10th of July, 2025 AEST
Key Points
Second-generation NorthStar and related devices approved under EU-MDR
European hospital pipeline expands from 7 to 26 in six months
US FDA 510(k) submission for NorthStar made, approval expected in 2025
PMA approval for ablation catheter and RF generator delayed due to FDA reviewer change
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