News|Articles|December 20, 2025

Contemporary OB/GYN week in review: FemVue clearance, flibanserin approval, and more

Review some of the top stories from the Contemporary OB/GYN website over the past week and catch up on anything you may have missed.

This week at Contemporary OB/GYN®, we covered topics ranging from the use of FemVue for in-office tubal assessment to how epilepsy impacts prenatal health. Click the links below to read anything you might have missed from Monday, December 15 to Friday, December 19, 2025.

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.

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.”

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FDA approves expanded use of flibanserin for hypoactive sexual desire disorder in women

The FDA has approved Addyi (flibanserin 100 mg) for the treatment of hypoactive sexual desire disorder (HSDD) in women younger than 65 years, according to an announcement from Sprout Pharmaceuticals. The decision expands the drug’s original indication and represents the first FDA approval specifically extending pharmacologic treatment options for postmenopausal women with HSDD.

“This milestone reflects a decade of persistent work with the FDA to fundamentally change how women’s sexual health is understood and prioritized,” said Cindy Eckert, founder and chief executive officer of Sprout Pharmaceuticals. “Over the years, we’ve pushed for the science to speak louder than the stigma—and today’s approval shows how far we’ve come. I want to congratulate the FDA for recognizing what millions of women have long deserved: equitable, science-backed care at every stage of life.”

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FDA grants 510(k) clearance to Revi System against urgency urinary incontinence

The FDA has provided 510(k) clearance to the Revi System for long-term management of urgency urinary incontinence (UUI), according to BlueWind Medical, Ltd.

The Revi System is a wearable device intended for increased efficacy in providing therapy to UUI patients. Recent updates to the system include a streamlined, easy-to-use design. The interface is smart and user-friendly, with a simple, 3-button control for easy patient use. These features increase patient confidence and control, making UUI management more convenient.

“Our strong clinical evidence and our focus on patient comfort and satisfaction show that when patients can personalize their therapy, outcomes improve,” said Kerry Nelson, CEO of BlueWind Medical. “The enhanced wearable continues that philosophy by making therapy easy to use, adaptable to each patient’s lifestyle, and supportive of long-term use.”

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Restrictive abortion laws linked to increased EMTALA violations

Researchers have identified negative impacts of restrictive abortion laws on frontline emergency care despite federal protections, publishing their findings in JAMA Health Forum.

According to the 1986 US Emergency Medical Treatment and Labor Act (EMTALA), all Medicare-participating hospitals must screen every emergency department patient and provide treatment. However, the study results indicated a significant increase in EMTALA violations in states that ban abortion with no exceptions for patients’ health.

“For pregnant patients, stabilization may mean ending a pregnancy when it presents a serious threat to the patient’s health,” said Liana Woskie, assistant professor at Tufts University. “When state laws narrow the circumstances in which clinicians feel safe intervening, it can delay essential care, which directly conflicts with Americans’ right to timely emergency care.”

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Michelle Manzo, MPH, CMPP, discusses epilepsy challenges in motherhood

In this Contemporary OB/GYN video, Michelle Manzo, MPH, CMPP, an epilepsy medical affairs outcomes researcher at UCB and a patient advocate, discusses the multifaceted challenges faced by women with epilepsy throughout their motherhood journey and outlines opportunities to improve care and outcomes.

Manzo explains that women of childbearing age with epilepsy often struggle with complex medication management, as they must balance seizure control with contraception, pregnancy safety, and postpartum considerations. This complexity is compounded by significant barriers to information.

Guidance is frequently inconsistent, conflicting, or difficult to access, particularly because women interact with multiple health care professionals—such as neurologists, obstetricians, and maternal-fetal medicine specialists—who may not always provide aligned recommendations. Stigma, fear of self-advocacy, and a lack of agency further contribute to stress, prompting many women to seek information and reassurance from peer communities.

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