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Echo IQ Advances FDA Approval Pathway for Heart Failure Tool
6:08pm on Sunday 1st of June, 2025 AEST
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Healthcare
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Echo IQ Advances FDA Approval Pathway for Heart Failure Tool
6:08pm on Sunday 1st of June, 2025 AEST
Key Points
Echo IQ requests pre-submission meeting with US FDA for EchoSolv HF validation trial
FDA clearance anticipated in second half of 2025, enabling US commercialisation
Pre-submission meeting signals advanced regulatory progress and study design finalisation
Company confirms compliance with ASX continuous disclosure obligations
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