Femasys has gained approval for its FemaSeed Intratubal Insemination product and two diagnostic devices from the Ministry of Health’s (AMAR) Israeli medical device division.
The diagnostic devices, FemCerv and FemVue, are designed to identify cervical cancer and tubal assessment, respectively.
Intended to improve fertilisation by delivering sperm directly into the fallopian tube, FemaSeed claims to provide a safe and cost-effective alternative for women, men, and couples struggling with infertility who are ready to conceive through the insemination process.
A pivotal trial demonstrated the ‘effectiveness’ of FemaSeed, particularly for cases of low male sperm count, offering a lower-risk alternative before considering in vitro fertilisation (IVF).
FemCerv, the first Food and Drug Administration (FDA)-cleared product specifically tailored for collecting a comprehensive and uncontaminated sample, facilitates a pain-free office procedure for cervical cancer identification. It has also gained approvals in Israel, Canada, and Europe.
FemVue, another diagnostic device for assessing fallopian tubes via ultrasound, has been cleared by the US regulator and approved in Canada, Israel, Europe and Japan.
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Headquartered in Atlanta, Femasys develops and commercialises minimally invasive women’s health solutions.
Companion diagnostic products FemCath and FemChec, used for FemBloc’s ultrasound-based confirmation test, have also been cleared by the FDA and gained approval in Canada and Europe.
Femasys CEO Kathy Lee-Sepsick said: “We remain committed to our mission of delivering critically important technological advancements to women globally, with Israel now added to our expanding reach.
“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 US and select other countries as we continue to expand the availability of our much-needed product solutions.”
In August 2024, the company secured CE mark certification and Health Canada approval for FemVue MINI, a compact solution for assessing fallopian tubes.
This article was originally published here.
