Biomedical company Femasys said it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its FemVue Controlled device, a 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.
“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 Inc. “FemVue Controlled reflects our commitment to simplifying care delivery while strengthening the scalability and efficiency of our product portfolio.”
FemVue Controlled delivers a consistent alternating pattern of saline and air as contrast media during ultrasound imaging to evaluate fallopian tube status.
