Femasys (FEMY) announced 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. “This FDA clearance represents an important milestone for Femasys as we continue to advance practical, clinician-focused innovations,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys. “FemVue Controlled reflects our commitment to simplifying care delivery while strengthening the scalability and efficiency of our product portfolio.”
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