Femasys Secures FDA IDE Approval to Advance Final FemBloc Trial Phase

Reuters11-03

Femasys Secures FDA IDE Approval to Advance Final FemBloc Trial Phase

Femasys Inc. announced that it has received U.S. Food and Drug Administration (FDA) Investigational Device Exemption $(IDE)$ approval to continue enrollment in the final phase (Part B) of the pivotal FINALE trial for FemBloc, its non-surgical permanent birth control device. This regulatory milestone follows successful completion of the first part of the trial and is a key step toward potential U.S. Pre-Market Approval (PMA) for FemBloc. The announcement is specific to Femasys Inc.; no other organizations were mentioned as recipients of the grant or regulatory approval.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Femasys Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9567053-en) on November 03, 2025, and is solely responsible for the information contained therein.

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