FDA Approves Teal Health’s At-Home Cervical Cancer Screening Device

Teal Health has received FDA approval for its Teal Wand, the first prescription-based at-home vaginal self-collection device for cervical cancer screening in the U.S. Designed for women aged 25–65 at average risk, the device enables HPV testing using Roche’s cobas HPV test, a guideline-recommended method for detecting the virus linked to cervical cancer. The device includes a collection kit and telehealth support, allowing users to consult with providers who prescribe the kit, review results, and offer guidance. FDA approval was supported by the SELF-CERV study, which demonstrated that self-collected samples matched clinical accuracy, with a 96% detection rate for cervical precancer. The study also found high user preference, with 94% favoring the Teal Wand and 86% saying it would help them stay current on screenings. Teal plans to launch in California next month, with national expansion to follow, and is working with insurers to ensure affordability and accessibility.

12-05-2025