
Femasys Announces Historic Milestone with European Approval of FemBloc®, the First Non-Surgical Permanent Birth Control
On Jun. 25, 2025, Femasys announces Conformité Européene (CE) mark certification under European Union Medical Device Regulation of the Class III FemBloc blended polymer component, marking the first regulatory approval in the world for the FemBloc® System for non-surgical female permanent birth control.
After European Medicines Agency (EMA) review, the Notified Body has granted CE mark certification. The regulatory approval for the blended polymer joins the earlier approval announced on March 13, 2025 for the delivery system component of FemBloc. The FemBloc System can now be marketed in the European Economic Area, which includes the 27 member states of the European Union and the 3 European Free Trade Association countries.
FemBloc® is a revolutionary, first-of-its-kind non-surgical solution for permanent birth control, addressing a large unmet need in women’s reproductive health. Delivered in-office through a patented delivery system, FemBloc places a proprietary blended polymer into both fallopian tubes, which safely degrades and forms natural scar tissue to permanently block them. In contrast to surgical sterilization, FemBloc eliminates the risks of anesthesia, infection, and recovery downtime, making it safer, more accessible, and significantly more cost-effective. With no comparable alternatives on the market, FemBloc represents a disruptive advancement with broad global potential.
Tags:
Source: Femasys
Credit:
