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Memphasys spots a potential faster path for Felix into US IVF
9:35am on Friday 25th of September, 2026 AEST
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Healthcare
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Memphasys spots a potential faster path for Felix into US IVF
9:35am on Friday 25th of September, 2026 AEST
Key Points
Potential 510(k) pathway identified for Felix
FDA Pre-Submission engagement to test proposed predicate and evidence
Formal submission targeted for Q1 CY2027
US IVF market estimated at US$5.9 billion
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