Business
Femasys Announces Historic Milestone with European Approval of FemBloc®, the First Non-Surgical Permanent Birth Control
--European CE mark approval of the entire FemBloc® system marks pivotal achievement in expanding safe, accessible and non-surgical permanent contraceptive options for women--ATLANTA, June 25, 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
About this update from Femasys Inc.
[{"type":"image","alt":"Femasys Inc.","displaySize":"","headline":null,"caption":"Femasys Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":122,"url":"https://media.zenfs.com/en/globenewswire.com/301b83514d43baad2f5211eaa290a825"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/GL8WCCgrHOHP9r8Vdi7XpQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE3MTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/301b83514d43baad2f5211eaa290a825","width":300,"height":122}},"lazy":false},{"type":"text","content":"--European CE mark approval of the entire FemBloc® system marks pivotal achievement in expanding safe, accessible and non-surgical permanent contraceptive options for women--","length":174,"tagName":"p"},{"type":"text","content":"ATLANTA, June 25, 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 2017/745) 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.","length":993,"tagName":"p"},{"type":"text","content":"“European approval of the entire FemBloc System represents a major milestone for Femasys and the field of women’s health. It marks the first global regulatory endorsement of our groundbreaking non-surgical permanent birth control solution, following a rigorous scientific evaluation of the technology. This achievement reflects years of dedication and underscores our commitment to bringing safe, accessible alternatives to traditional surgical options,” stated Kathy Lee-Sepsick, Femasys’ CEO and Founder. “Femasys is preparing to make FemBloc commercially available through...