Femasys Secures FDA IDE Approval to Advance Final FemBloc Trial Phase
Femasys Inc. has received FDA Investigational Device Exemption (IDE) approval to proceed with enrollment in the final phase of the FINALE trial for its FemBloc birth control device. This approval follows the successful completion of the trial's first part and is a significant step towards obtaining U.S. Pre-Market Approval (PMA) for FemBloc. The announcement pertains solely to Femasys Inc.
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. © Copyright 2025 - Public Technologies (PUBT)
