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Femasys Receives 510(k) Clearance From FDA To Market FemChec For Fallopian Tube Diagnosis

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News
rttnewslogo20mar2024

Biomedical company Femasys, Inc. (FEMY) announced Monday it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for FemChec, an innovative diagnostic solution for checking the fallopian tubes, designed for controlled delivery of contrast for confirmation of tubal status.

In addition to 510(k) clearance, FemChec, a contrast generating product, is an integral part of the confirmation test following administration of FemBloc non-surgical permanent birth control, currently in late-stage pivotal trial.

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