FDA Approves FemBloc Modular PMA Pathway

Femasys Inc. announced that the U.S. United States — Food and Drug Administration (FDA) has approved the company's modular premarket approval (PMA) pathway for FemBloc, its investigational non-surgical permanent birth control technology. This approval allows key components of the submission to be reviewed by the FDA in advance of the final clinical data, providing a clear and efficient framework for advancing FemBloc toward U.S. approval. FemBloc is designed to be delivered in an OB/GYN office without anesthesia, incisions, or recovery time, offering a more convenient and affordable alternative to surgical sterilization. The technology is already approved for marketing in Europe, the UK, and New Zealand. Femasys is also building a U.S. commercial team to support its fertility portfolio and ultimately FemBloc. Following the announcement, Femasys shares rose more than 40% in premarket trading.