Femasys has received approval from the Ministry of Health’s Israeli Medical Device Division (AMAR) for its innovative FemaSeed Intratubal Insemination product, alongside two diagnostic devices, FemCerv and FemVue. These products are aimed at addressing critical needs in women’s health, particularly in infertility and cervical cancer detection.
The FemaSeed device is designed to improve fertilization by directly delivering sperm into the fallopian tubes, offering a safer, more affordable option for couples struggling with infertility. It is especially beneficial for cases of low male sperm count, providing an alternative to in vitro fertilization (IVF) with reduced risk.
FemCerv, cleared by the FDA, is the first device of its kind to enable a painless and efficient procedure for cervical cancer identification, providing a clean, uncontaminated sample for analysis. This product has already gained approval in multiple regions, including Israel, Canada, and Europe. FemVue, which assesses the health of fallopian tubes using ultrasound, has been cleared by the US FDA and is approved in Canada, Israel, Europe, and Japan.
Femasys, headquartered in Atlanta, is dedicated to developing and commercializing minimally invasive health solutions for women. In addition to FemaSeed, the company’s diagnostic portfolio includes FemCath and FemChec, which work in tandem with FemBloc’s ultrasound-based confirmation test and have earned FDA clearance as well as approval in Canada and Europe.
CEO Kathy Lee-Sepsick expressed the company’s commitment to enhancing women’s health globally, emphasizing Femasys’s growing international footprint, with Israel as a new addition. She highlighted that the company’s suite of products aims to provide women with better, more accessible, and lower-cost options.
In a recent development, Femasys also secured CE mark certification and Health Canada approval for FemVue MINI in August 2024, a compact version designed for assessing fallopian tubes. The company remains focused on expanding its reach, particularly in the US and select international markets.
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