Femasys has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for FemChec, a diagnostic solution to check the fallopian tubes. It’s designed for controlled delivery of contrast to confirm tubal status.
 
FemChec instills through controlled delivery, a consistent alternating pattern of saline and air in a continuous stream of contrast media. When it’s used with an intrauterine catheter, it offers controlled delivery of natural contrast during an ultrasound evaluation of the fallopian tubes with or without the uterine cavity.
 
The company is amid an ongoing pivotal clinical trial for FemBloc, its non-surgical permanent birth control of which FemChec is part of the confirmation test to confirm success. In addition to FDA clearance, FemChec also has regulatory approval in China.
 
“FemChec is an essential part of our suite of women’s health products, as it fortifies our position to provide safe and technologically-advanced diagnostic and therapeutic solutions addressing women’s healthcare needs,” said Femasys founder and CEO Kathy-Lee Sepsick. “In particular, FemChec is a key element of our FemBloc non-surgical permanent birth control solution as it allows for confirmation of procedure success by the same practitioner using natural contrast and ultrasound. This is opposed to the traditional methodology, which requires a referral to radiology, utilizes x-ray dye, and unnecessarily exposes the woman to radiation. We look forward to continuing to work with FDA as we progress our FemBloc solution through the FINALE pivotal trial, which is currently enrolling.”

Check out MPO’s interview with Kathy-Lee Sepsick in the “Medtech Matters” podcast here!