FDA clears FemVue Controlled for in-office tubal assessment

The FDA has granted 510(k) clearance to the FemVue Controlled device for assessing fallopian tube status, according to Femasys Inc.¹

FemVue was designed to assess fallopian tubes through a controlled contrast delivery. The newest device includes both FemVue and FemChec technologies, streamlining both manufacturing and use in practice while allowing multiple clinical uses. During ultrasound imaging, it consistently alters between saline and air as contrast media.

“This FDA clearance represents an important milestone… as we continue to advance practical, clinician-focused innovations,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. “FemVue Controlled reflects our commitment to simplifying care delivery while strengthening the scalability and efficiency of our product portfolio.”

Using the Femvue Controlled device, clinicians can screen their patients for tubal infertility, also known as blocked tubes.² Safety and tolerability have been proven for the device, which prevents exposure to radiation and the iodine-based contrast dye used in hysterosalpingography.

The speed of Femvue has also been highlighted. Results can be provided immediately to the patient after the test, which takes approximately 10 to 15 minutes to perform. This allows clinicians and their patients to immediately begin discussing the next steps to take.

Compared to a radiology referral, FemVue is also significantly more affordable. Overall infertility work-up costs also may be reduced for patients using FemVue. Finally, the test is performed by a gynecologist in their office, creating a comfortable environment for patients and their partners to watch the test and receive results.

Contraindications of FemVue include conditions that are contraindications of hysterosalpingography and current or recent pregnancy. Similar accuracy to alternative fluoroscopic X-rays has been reported, highlighting the efficacy of the device and supporting the FDA’s clearance.

References

1. Femasys secures US FDA clearance for next-generation FemVue diagnostic device. Femsays Inc. December 18, 2025. https://www.globenewswire.com/news-release/2025/12/18/3207832/0/en/Femasys-Secures-U-S-FDA-Clearance-for-Next-Generation-FemVue-Diagnostic-Device.html
2. The FemVue test. Femsays Inc. Accessed December 18, 2025.