Femasys Secures FDA IDE Approval to Advance Final FemBloc Trial Phase

Reuters
2025.11.03 13:30
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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.