Core Insights - Femasys Inc. has received FDA 510(k) clearance for its FemVue Controlled device, which integrates FemVue and FemChec technologies to enhance fallopian tube evaluation and improve workflow efficiency [1][2] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a patent-protected portfolio of therapeutic and diagnostic products [3] - The company is actively commercializing its lead product innovations in the U.S. and key international markets, including FemaSeed and FemVue [3] Product Details - The FemVue Controlled device is designed for controlled delivery of saline and air as contrast media during ultrasound imaging to evaluate fallopian tube status, enabling multiple clinical uses in one solution [2] - Femasys' fertility portfolio includes FemaSeed, which is over twice as effective as traditional intrauterine insemination (IUI) with a comparable safety profile [3] Recent Developments - FemBloc, a non-surgical permanent birth control method, received full regulatory approval in Europe, the UK, and New Zealand in 2025, with commercialization planned through strategic partnerships [4] - The FemChec product provides an ultrasound-based test to confirm procedural success, demonstrating compelling effectiveness and high satisfaction rates in initial clinical trials [4]