FDA Approves Femasys’ FemCheck, Paving the Way for Non-Surgical Permanent Birth Control Options

Femasys, a company focused on non-surgical permanent birth control for women, has gained FDA clearance for FemCheck, a diagnostic device designed to assess fallopian tube occlusion. The 510(k) clearance allows FemCheck to deliver a controlled contrast solution to the fallopian tubes for evaluation during ultrasound procedures.

This innovative device works with an intrauterine catheter, using a mix of saline and air to create a continuous stream of contrast media. While it can be used for assessing the fallopian tubes with or without evaluating the uterine cavity, its primary role will be in conjunction with Femasys’ FemBloc, a biopolymer-based product for permanent birth control.

FemBloc, delivered via balloon catheters, solidifies within the fallopian tubes, leading to scar tissue formation that blocks the tubes as the biopolymer degrades. Currently, the only permanent birth control option for women is tubal ligation, a surgical procedure.

FemCheck is being employed in Femasys’ ongoing FINALE pivotal trial to confirm the success of FemBloc. According to Femasys CEO Kathy-Lee Sepsick, FemCheck's ultrasound-based evaluation offers a radiation-free alternative to traditional X-ray dye methods.