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Femasys Announces Israeli Regulatory Approvals for FemaSeed® for Female Infertility Treatment and Two Diagnostic Devices
Regulatory approval follows FemaSeed U.S. FDA-clearance announced September 2023 and EU CE mark approval announced June 2024 ATLANTA, Feb. 04, 2025 (GLOBE
About this update from Femasys Inc.
[{"type":"text","content":"Regulatory approval follows FemaSeed U.S. FDA-clearance announced September 2023 and EU CE mark approval announced June 2024\nATLANTA, Feb. 04, 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 the receipt of the Israeli Medical Device Division of the Ministry of Health’s (AMAR) approvals for the FemaSeed® Intratubal Insemination product for female infertility treatment and two diagnostic devices, FemVue® for tubal evaluation and FemCerv® for cervical cancer detection. “We remain committed to our mission of delivering critically important technological advancements to women globally, with Israel now added to our expanding reach.” stated Kathy Lee-Sepsick, Femasys’ CEO. “FemaSeed, along with our entire suite of products, has been developed to provide women with better, lower-cost and more accessible options. We remain focused on commercial execution in the U.S. and select other countries as we continue to expand the availability of our much-needed product solutions.” About FemaSeedFemaSeed® is an innovative advancement in artificial insemination, designed to enhance fertilization by precisely delivering sperm into the fallopian tube, the natural site of conception. It offers a safe, accessible and cost-effective first-line therapeutic option for infertile women, men and couples seeking pregnancy through insemination. FemaSeed offers a revolutionary alternative to IUI, enabling healthcare professionals to expand their practice services with a more effective approach as demonstrated in the pivotal trial (NCT0468847) for low male sperm count.1 It serves as an affordable, less burdensome and lower-risk first step before IVF. Learn more at www.femaseed.com. About FemVue FemVue® is the first FDA-cleared product that creates natural saline and air contrast for a safe, reliable, real-time evaluation of the fallopian tubes using ultrasound. When combined with a uterine cavity assessment, it provides a comprehensive exam in the comfort of the gynecologist’s office. Since FemaSeed infertility treatment requires at least one open fallopian tube, FemVue is an essential companion diagnostic. Learn more at www.femvue.com. About FemCerv FemCer...