Livi is a single-use, soft polyurethane foam device cleared by the FDA to absorb semen and vaginal discharge within approximately 60 seconds.
The FDA granted clearance on March 24, 2026, to Livi, a novel device designed to support vaginal health by absorbing semen and other post-intercourse fluids. Developed by LiviWell, the product represents the introduction of a new category in intimate health care intended to address common concerns following intercourse. These include symptoms of odor and discharge, which are associated with infections like bacterial vaginosis, according to LiviWell.1,2
The regulatory milestone followed a formal submission process that began on July 2, 2025. During the initial filing, the company positioned the device as a tool to help maintain a healthy vaginal microbiome by addressing symptoms such as odor and discharge, which are frequently associated with conditions like bacterial vaginosis. The development of the technology was supported by anchor investor Atlantic Health System, which provided the necessary resources to advance the device through critical research and development milestones and the federal review period.²
The clinical necessity for the device was driven by research into how semen affects the vaginal environment. Michael Ingber, MD, a board-certified urogynecologist and chief medical officer of LiviWell, noted that semen can disrupt vaginal pH, contributing to common complaints regarding post-intercourse discharge and odor.1,2 Prior to the introduction of this device, options for managing these everyday sexual health concerns were limited, often leaving patients with unaddressed symptoms.²
"Conversations around post-sex vaginal health have historically been limited,” said Ingber in a news release. “Achieving FDA clearance for Livi represents an important step toward bringing greater medical recognition and innovative solutions to women experiencing these everyday concerns."1
Livi was engineered as a single-use device made from soft polyurethane foam. It utilized an applicator similar in design and function to a standard tampon for insertion into the vagina after intercourse. The device was designed to absorb fluids “as fast as approximately 60 seconds,” the company stated in the clearance announcement. The cleared labeling indicated that the device may be used for a duration of up to 15 minutes following intercourse before removal.
"For too long, the realities women experience after sex have gone largely unaddressed by innovation,” said Dawn Halkuff, CEO of LiviWell, in a statement. “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."
Following the regulatory approval, the company established a timeline for commercial availability. Livi is expected to become available to consumers in the United States at the end of May 2026. The initial launch strategy focused on online sales, with the company indicating future plans to expand distribution into traditional retail channels.
When LiviWell first announced the submission for regulatory clearance in July 2025, the company emphasized that the product was rooted in years of dedicated research. At that time, the goal was to provide women with more tools to manage their sexual health through science-based consumer products. The submission was part of a broader mission to advance intimate health through products that fit seamlessly into existing routines while providing medical-grade recognition for common vaginal health issues.²
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