Femasys has received US Food and Drug Administration (FDA) clearance for its FemChec pressure management device, designed to deliver a low-pressure hysterosalpingography as a confirmation test following sterilisation surgery.
FemChec uses patent-pending technology that limits the applied intrauterine pressure to 200 mmHg, allowing physicians to meet the requirements of the mandatory hysterosalpingography confirmation test, while minimising improperly performed tests and procedure complications.
Femasys president and CEO Kathy Lee-Sepsick said the FemChec provides benefits to the physician and patient as a properly performed low-pressure confirmation test is critical to relying on the permanent sterilisation procedure long-term.
The company expects to market the first device in the US in December 2011.
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