Femasys Inc (Nasdaq:FEMY), a biomedical innovator focused on addressing unmet needs in women's health, announced on Thursday that it has received Conformité Européene (CE) mark certification for its FemBloc delivery system, a non-surgical approach to permanent birth control for women.

This approval represents a significant milestone in the availability of FemBloc, which offers a minimally invasive, non-surgical alternative to traditional sterilisation methods.

The FemBloc system delivers a proprietary synthetic tissue adhesive to both fallopian tubes, creating non-functional scar tissue that permanently blocks the tubes. Over time, the blended polymer fully degrades.

The approval follows a successful G12 Special MDR Audit for Class III devices, with the European Medical Agency (EMA) expected to complete its review by mid-2025.

According to Femasys, its innovation provides a lower-cost, less risky option for permanent birth control, offering a significant advancement over surgical procedures.