Femasys Receives FDA Clearance for FemChec Fallopian Tube Diagnostic
Key Insights
Femasys Inc. has received FDA 510(k) clearance for FemChec (search), a diagnostic solution designed for checking the fallopian tubes using controlled contrast delivery.
FemChec (search) is intended for use with an intrauterine catheter, delivering a consistent stream of saline and air for ultrasound evaluation of the fallopian tubes.
The device is a key component of Femasys' FemBloc (search) non-surgical permanent birth control solution, confirming procedure success with natural contrast and ultrasound.
Femasys, Inc. (Nasdaq: FEMY) has secured FDA 510(k) clearance for its innovative diagnostic solution, FemChec (search), designed for assessing the fallopian tubes. This advancement promises a safer, more accessible method for women's health diagnostics. The clearance marks a significant step forward for Femasys in its mission to address unmet needs in women's healthcare.
FemChec (search) is designed for the controlled delivery of contrast media to confirm tubal status during ultrasound evaluations. It employs a unique method, alternating between saline and air in a continuous stream, providing natural contrast during the procedure.
Key Benefits of FemChec
Kathy-Lee Sepsick, Femasys Founder and CEO, emphasized that "FemChec (search) 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." She added that FemChec is a key element of their FemBloc (search) non-surgical permanent birth control solution, allowing for confirmation of procedure success by the same practitioner using natural contrast and ultrasound.
The traditional methodology often requires a referral to radiology, utilizes x-ray dye, and unnecessarily exposes women to radiation. FemChec (search) aims to mitigate these risks by offering an in-office solution that relies on natural contrast and ultrasound technology.
FemChec's Role in FemBloc Trial
FemChec (search) is integral to the ongoing FINALE pivotal trial for FemBloc (search), Femasys' non-surgical permanent birth control solution. The diagnostic tool is used to confirm the success of the FemBloc procedure, ensuring that the biopolymer implant effectively occludes the fallopian tubes.
About Femasys
Femasys is dedicated to addressing significant unmet needs in women's health through innovative therapeutic and diagnostic solutions. Their portfolio includes FemaSeed Intratubal Insemination, an FDA-cleared infertility (search) treatment, and FemBloc (search), a non-surgical permanent birth control method in late-stage clinical development. The company's diagnostic products, such as FemVue and FemCerv, complement their therapeutic offerings, providing comprehensive solutions for women's healthcare needs.