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Femasys Announces FemBloc Delivery System Approval in Europe; A Significant Step Towards FemBloc Permanent Birth Control Availability as the First-Ever Non-Surgical Approach

Provided By GlobeNewswire

Last update: Mar 13, 2025

ATLANTA, March 13, 2025 (GLOBE NEWSWIRE) -- Femasys Inc., (Nasdaq: FEMY), a leading biomedical innovator addressing significant unmet needs in women's health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products, announces Conformité Européene (CE) mark certification under European Union Medical Device Regulation (EU MDR) as the first regulatory approval in the world for the FemBloc® delivery system for non-surgical female permanent birth control. For the FemBloc blended polymer, an integral part of the FemBloc permanent birth control, the Company has successfully completed an expedited G12 Special MDR Audit for Class III devices and the Notified Body has recommended for CE mark approval pending the final stages of European Medical Agency (EMA) review, with potential approval expected mid-2025.

Read more at globenewswire.com

FEMASYS INC

NASDAQ:FEMY (7/28/2025, 10:17:21 AM)

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