FDA Clears Controlled Contrast Delivery Method for Ultrasound Imaging of Fallopian Tubes

The Food and Drug Administration (FDA) has granted 510(k) clearance for FemChec®, a modality that generates natural contrast for use in ultrasound imaging of fallopian tubes. This imaging may potentially be utilized to confirm the success of FemBloc®, a non-surgical approach to permanent birth control that is currently being evaluated in a clinical trial.

Using an intrauterine catheter, clinicians can employ FemChec to provide a continuous contrast media stream of alternating saline and air to enhance ultrasound visualization of the fallopian tubes with or without the uterine cavity, according to Femasys, the developer of FemChec and FemBloc.

The company said the combination of natural contrast and ultrasound may provide a viable alternative to traditional X-ray and corresponding radiation exposure for evaluating fallopian tubes.

“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 health care needs,” noted Kathy-Lee Sepsick, the chief executive officer and founder of Femasys.