Femasys today announced it received FDA 510(k) clearance for its FemChec contrast-generating device that checks fallopian tubal status.

Atlanta-based Femasys designed FemChec for controlled delivery of contrast to confirm tubal status. It alternates between a pattern of saline and air in a continuous stream of contrast media.

“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,” CEO Kathy-Lee Sepsick said in a news release. “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.”

When used with an intrauterine catheter, it is intended to control delivery of natural contrast during an ultrasound evaluation of the fallopian tubes with or without the uterine cavity.

Femasys is currently supporting an ongoing pivotal clinical trial for its FemBloc non-surgical permanent birth control, of which FemCheck is part of the confirmation test used to confirm its success.

“We look forward to continuing to work with FDA as we progress our FemBloc solution through the FINALE pivotal trial, which is currently enrolling,” Sepsick said.