Memphasys Targets Potentially Faster US Regulatory Approval Pathway for Sperm Separation System
MT Newswires Live
Sep 25
Memphasys (ASX:MEM) said a reassessment of its US regulatory strategy for the Felix sperm separation system identified a potentially faster, cost effective, and more direct pathway toward US Food and Drug Administration (FDA) clearance, according to a Friday filing with the Australian bourse.
The company, which was previously contemplating the more complex De Novo pathway for Felix, said it identified a medical device it believes may provide an appropriate predicate, potentially allowing the device to pursue the FDA's more established 510(k) clearance pathway.
Memphasys will now engage with the FDA to seek feedback on the proposed pathway before proceeding to a formal submission, it said.
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