Business
Femasys Secures U.S. FDA Clearance for Next-Generation FemVue Diagnostic Device
-- Innovative single-device solution integrates proven FemVue and FemChec® technologies to support fallopian tube evaluation and improve workflow efficiency-- ATLANTA, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced today it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its FemVue Con
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":"-- Innovative single-device solution integrates proven FemVue and FemChec® technologies to support fallopian tube evaluation and improve workflow efficiency--","length":158,"tagName":"p"},{"type":"text","content":"ATLANTA, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced today it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its FemVue Controlled device, an innovative diagnostic solution designed for controlled contrast delivery to evaluate fallopian tube status. The next-generation FemVue Controlled device integrates features of the Company’s original FemVue and FemChec technologies into a single FDA-cleared product, enabling multiple clinical uses while streamlining manufacturing and practice workflows.","length":714,"tagName":"p"},{"type":"text","content":"“This FDA clearance represents an important milestone for Femasys as we continue to advance practical, clinician-focused innovations,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. “FemVue Controlled reflects our commitment to simplifying care delivery while strengthening the scalability and efficiency of our product portfolio.”","length":360,"tagName":"p"},{"type":"text","content":"About FemVue ControlledFemVue® Controlled is an FDA-cleared diagnostic device designed for controlled delivery of a consistent alternating pattern of saline and air as contrast media during ultrasound imaging to evaluate fallopian tube status. The next-generation device integrates features of the Company’s FemVue and FemChec® technologies into a single platform, enabling multiple clinical uses within one solution, including confirmation of tubal pate...