Femasys Receives 510(k) Clearance From FDA For FemVue Controlled Device, Diagnostic Solution For Controlled Contrast Delivery To Evaluate Fallopian Tube Status

Benzinga · 2d ago

-- Innovative single-device solution integrates proven FemVue and FemChec® technologies to support fallopian tube evaluation and improve workflow efficiency--

ATLANTA, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ:FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced today it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its FemVue Controlled device, an innovative diagnostic solution designed for controlled contrast delivery to evaluate fallopian tube status. The next-generation FemVue Controlled device integrates features of the Company's original FemVue and FemChec technologies into a single FDA-cleared product, enabling multiple clinical uses while streamlining manufacturing and practice workflows.