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Femasys Inc. Receives U.S. FDA Clearance to Market FemChec®, an Innovative Diagnostic Solution for Fallopian Tube Check
In addition to 510(k) clearance, FemChec, a contrast generating product, is an integral part of the confirmation test following administration of FemBloc
About this update from Femasys Inc.
[{"type":"text","content":"In addition to 510(k) clearance, FemChec, a contrast generating product, is an integral part of the confirmation test following administration of FemBloc non-surgical permanent birth control, currently in late-stage pivotal trial\nATLANTA, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for FemChec®, an innovative diagnostic solution for checking the fallopian tubes, designed for controlled delivery of contrast for confirmation of tubal status. Kathy-Lee Sepsick, Femasys Founder and CEO commented, “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.” About FemChec® FemChec is an innovative diagnostic solution designed to instill through controlled delivery, a consistent alternating pattern of saline and air in a continuous stream of contrast media. When used with an intrauterine catheter, it is intended for the controlled delivery of natural contrast during an ultrasound evaluation of the fallopian tubes with or without the uterine cavity. Femasys is supporting an ongoing pivotal clinical trial for our FemBloc non-surgical permanent birth control of which FemChec is part of the confirmation test utilized to confirm success. FemChec has achieved U.S. FDA clearance and regulatory approval in Canada. About Femasys Femasys is a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of ...