US-based biomedical technology company Femasys has secured regulatory approval for its female infertility product FemaSeed and diagnostic devices FemVue and FemCerv in Israel.

Israel’s Medical Device Division of the Ministry of Health (AMAR) granted the approval.

FemaSeed is an advanced artificial insemination product designed to enhance fertilisation by delivering sperm directly into the fallopian tube, where natural conception occurs.

It provides a safe, accessible, and low-cost therapeutic option for infertile women, men, and couples seeking pregnancy through insemination.

The regulatory approval in Israel follows the US Food and Drug Administration (FDA) approval of FemaSeed in September 2023 and the CE mark approval in June 2024

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.”

FemVue is an FDA-approved 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, FemVue provides a comprehensive exam within the comfort of a gynaecologist’s office.

FemVue serves as a companion diagnostic tool for FemaSeed treatment, which requires at least one open fallopian tube.

FemCerv is an FDA-approved product specifically designed to collect a complete and uncontaminated sample in a pain-free procedure for cervical cancer detection.

The device aims to improve the diagnostic process for cervical cancer providing a more comfortable experience for patients.

Based in Atlanta, Femasys develops and commercialises a portfolio of patent-protected, minimally invasive women’s health solutions, domestically manufactured in the US.