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Femasys Inc. Receives U.S. FDA Clearance to Market FemChec®, an Innovative Diagnostic Solution for Fallopian Tube Check
femasysfemasys(US:FEMY) GlobeNewswire News Room·2024-09-09 12:30

Core Insights - Femasys, Inc. has received 510(k) clearance from the FDA for its innovative diagnostic solution, FemChec, aimed at assessing fallopian tube status [1][2] - FemChec is designed to provide a safer alternative for confirming tubal status using natural contrast and ultrasound, eliminating the need for radiation exposure associated with traditional methods [2][3] - The company is advancing its FemBloc non-surgical permanent birth control solution through ongoing clinical trials, with FemChec being a key component for confirming procedure success [2][3] Company Overview - Femasys is a biomedical company focused on addressing unmet needs in women's healthcare with a range of innovative therapeutic and diagnostic products [4] - The company’s product portfolio includes FDA-cleared solutions such as FemaSeed for infertility treatment and FemBloc for non-surgical permanent birth control, which is positioned as a safer and cost-effective alternative to surgical methods [4] - Femasys has developed complementary diagnostic products, including FemVue and FemCerv, which have received regulatory approvals in multiple regions, including the U.S., Canada, and Europe [4]