LiviWell Secures FDA Clearance for Livi, Introducing a New Category in Post-Intercourse Vaginal Care

MOUNTAIN LAKES, N.J., March 24, 2026 /PRNewswire/ -- LiviWell, a women's health company dedicated to developing innovative solutions for intimate health, today announced that the U.S. Food and Drug Administration (FDA) has cleared Livi, a first-of-its-kind device designed to support vaginal health by absorbing semen and other post-intercourse fluids.

The FDA clearance marks a significant achievement for LiviWell and introduces Livi as a first-of-its-kind device intended for insertion into the vagina and designed to absorb semen or other vaginal discharge following intercourse.

"Receiving FDA clearance for Livi marks a defining milestone for LiviWell and signals the introduction of a new category in women's intimate health," said Dawn Halkuff, Chief Executive Officer of LiviWell. "For too long, the realities women experience after sex have gone largely unaddressed by innovation. This clearance allows us to bring a simple, easy-to-use solution to market - one that fits seamlessly into a woman's routine and helps her feel more comfortable and confident."

The single-use device is made from soft polyurethane foam and is inserted using an applicator similar in design and function to a tampon. Inserted after intercourse, the device absorbs fluid as fast as approximately 60 seconds and may be used for up to 15 minutes following intercourse before removal.

"From a clinical perspective, many patients have questions about post-sex complaints such as discharge and odor," said Dr. Michael Ingber, MD, board-certified urogynecologist, Co-Founder and Chief Medical Officer of LiviWell. "Our research has shown that semen disrupts vaginal pH and can contribute to those common post-intercourse complaints. Conversations around post-sex vaginal health have historically been limited. Achieving FDA clearance for Livi represents an important step toward bringing greater medical recognition and innovative solutions to women experiencing these everyday concerns."

Livi is expected to become available to consumers in the United States at the end of May 2026, initially through online sales, with plans to expand distribution into retail channels in the future.

For more information, visit www.MyLivi.com.

About LiviWell

LiviWell is a women's health company based in Mountain Lakes, New Jersey, dedicated to developing innovative solutions for women's intimate health and wellness. The company combines cutting-edge technology with rigorous clinical validation to bring transformative products to market that address unmet needs in women's sexual health. For more information, visit www.MyLivi.com.

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SOURCE LiviWell