Femasys, a biomedical company specializing in women’s health, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for FemChec, adiagnostic tool for checking the fallopian tubes. This new solution is designed for controlled delivery of contrast media, allowing for clearer confirmation of tubal status during ultrasound evaluations.
Kathy Lee-Sepsick, founder and CEO of Femasys, highlighted the importance of this advancement: “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. 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.”
The FemChec system represents a significant step forward in facilitating safer and more efficient diagnostic processes directly within a clinician’s office. It uses a unique method that combines saline and air to create a continuous stream of natural contrast, which is less invasive and reduces the need for radiological intervention.
