Key FDA approvals in women’s health: First half of 2025

Key FDA approvals in women’s health: First half of 2025 | Image Credit: © Postmodern Studio - stock.adobe.com.

The first half of 2025 has brought several pivotal FDA approvals that are expanding access to care, advancing diagnostic accuracy, and addressing long-standing gaps in women’s health.

From the first-in-class oral antibiotic gepotidacin for UTIs to AI-assisted fetal anomaly detection and at-home tools for STI and cervical cancer screening, these innovations reflect a growing shift toward personalized, accessible, and preventive care. Each approval highlights how regulatory progress is helping clinicians deliver faster diagnoses and more effective treatments for women across the reproductive lifespan.

In this recap, Contemporary OB/GYN reviews 4 of the most impactful FDA authorizations shaping clinical practice in 2025.

2025 regulatory updates in ob-gyn

FDA approves gepotidacin for uncomplicated UTI treatment

The FDA approved gepotidacin (Blujepa; GSK) for the treatment of uncomplicated urinary tract infections (uUTIs) in female patients aged 12 years and older on March 25, 2025, marking the first oral antibiotic in a new class in over 20 years. Clinical trials demonstrated its superiority over nitrofurantoin, with higher therapeutic success rates and a lower potential for resistance development.

The drug exhibited a favorable safety profile, with gastrointestinal adverse events being the most commonly reported side effects. Given the increasing prevalence of antibiotic-resistant uUTIs, gepotidacin represents a valuable new option for patients in need of effective treatment.

FDA approves Visby’s test for at-home STI identification

The FDA granted marketing authorization for the Visby Medical Women’s Sexual Health Test on March 28, 2025, making it the first at-home, prescription-free test for chlamydia, gonorrhea, and trichomoniasis. Designed for symptomatic and asymptomatic female patients, the test delivers results within approximately 30 minutes through the Visby Medical App.

Clinical evaluations demonstrated high accuracy rates, with sensitivity and specificity exceeding 97% for all 3 infections. While the FDA emphasized the importance of follow-up care, this approval marks a significant advancement in sexual health diagnostics by improving accessibility and reducing barriers to timely testing.

FDA clears Sonio Suspect AI for fetal anomaly detection

The FDA cleared the Sonio Suspect AI model for detecting fetal anomalies on February 24, 2025, offering a 22-point improvement in reader performance and enhancing early and accurate diagnoses. The technology integrates real-time AI quality control with anomaly detection, addressing gaps in prenatal ultrasound screenings, where up to 51% of anomalies go undetected.

Clinical studies demonstrated its efficacy across diverse patient demographics and clinician backgrounds, with the model significantly improving detection rates of brain and heart structures. By enabling earlier identification of congenital malformations, Sonio Suspect supports timely interventions, ultimately improving maternal and fetal health outcomes.

FDA approves Teal Wand for at-home cervical cancer screening

The FDA approved the Teal Wand on May 9, 2025, as the first at-home vaginal self-collection device for cervical cancer screening in U.S. women. Designed for women aged 25 to 65 at average risk, the device demonstrated 96% accuracy in identifying cervical precancer in the SELF-CERV trial and showed strong user preference and ease of use. The Teal Wand offers a comfortable alternative to traditional Pap smears and may help increase screening rates, especially among underserved populations. Nationwide availability is expected to follow its June launch in California, with insurance support aimed at reducing access barriers.