Femasys receives FDA 510(k) clearance for next-gen FemVue Controlled device

FEMASYS INC

FDA 510(k) clearance for FemVue Controlled, integrating FemVue and FemChec technologies.
Single-device solution for controlled contrast delivery to evaluate fallopian tube status.
Designed to enable multiple clinical uses and streamline manufacturing and practice workflows.
CEO Kathy Lee-Sepsick highlights milestone as advancing clinician-focused innovations.
NASDAQ-ticker FEMY; clearance announced December 18, 2025.

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