Femasys Permanent Birth Control Solution Gets 510(k) Clearance
Femasys (FEMY) said Monday it has received 510(k) clearance from the US Food and Drug Administration for FemChec, a tool designed for controlled delivery of contrast to check the status of fallopian tubes.
It is part of the company's non-surgical permanent birth control method, dubbed FemBloc, Femasys said.
The company added that it will continue to work with the regulator as FemBloc moves through a late-stage trial that is currently enrolling.
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