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.