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.”

Application in tubal infertility screening

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, according to Femasys. Overall infertility work-up costs may also 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.

Fembloc for permanent nonhormonal contraception

Femasys has continuously worked to provide fertility and non-surgical permanent birth control options for patients, including the novel transcervical birth control option FemBloc, which was discussed by Scott Chudnoff, MD, chair of obstetrics and gynecology at Maimonides Health, in a recent interview with Contemporary OB/GYN.³

According to Chudnoff, FemBloc will be evaluated in a pivotal clinical trial following an Investigational Device Exemption from the FDA, which was granted following 3 prior trials that all demonstrated a strong safety profile. There were no severe adverse events, and minor side effects were consistent with what clinicians expected from a transcervical procedure.

No incisions and no general anesthesia are required when inserting Fembloc, and the procedure does not leave behind any permanent implant. Chudnoff highlighted the simple “in-and-out” office-based experience of receiving it as a nonhormonal permanent birth control option. This eliminates multiple barriers traditionally linked to surgical sterilization.

“This is something that, as it further develops, there’s a palpable excitement about it, because historically, the idea of finding a transcervical option when the original options that were released were met with incredible enthusiasm, and I think that we’re [going to] see the same response with this,” said Chudnoff.

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. https://www.femvue.com/AboutFemVue
3. Chudnoff S. Scott Chudnoff, MD, highlights the benefits of Fembloc for permanent contraception. Contemporary OB/GYN. November 23, 2025. Accessed December 18, 2025. https://www.contemporaryobgyn.net/view/scott-chudnoff-md-highlights-the-benefits-of-fembloc-for-permanent-contraception