regulatory
confidence high
sentiment positive
materiality 0.65
Femasys gets CE mark for FemBloc delivery system in Europe, polymer approval expected mid-2025
FEMASYS INC
- FemBloc delivery system receives first-in-world CE mark certification under EU MDR for non-surgical permanent birth control.
- FemBloc blended polymer completes G12 Special MDR Audit; Notified Body recommends CE mark pending EMA review, approval expected mid-2025.
- Company continues enrolling participants in FDA IDE-approved pivotal clinical trial for U.S. approval of FemBloc.
- CEO Kathy Lee-Sepsick highlights FemBloc as a safer, accessible alternative to surgical sterilization, the only option today.