US FDA approves first and only at-home self-collection device for cervical cancer screening

May 12, 2025 | Monday | News

Cervical cancer is one of the only cancers that is almost entirely preventable with regular screening

Teal Health, a women's health company on a mission to eliminate cervical cancer, has announced the US Food and Drug Administration's (FDA) approval of the Teal Wand, the first and only at-home vaginal sample self-collection device for cervical cancer screening in the United States (US).

Cervical cancer screenings, commonly referred to as the Pap smear, are critical to a woman's health, but they are inconvenient and uncomfortable for most. Now women have a new way to screen that is as accurate as going to the doctor's office, comfortable, and done from home.

The Teal Wand is a prescription device that will soon be available at getteal.com for individuals aged 25–65 at average risk. The at-home screening includes both the Teal Wand collection kit and an end-to-end telehealth service providing virtual access to Teal medical providers who prescribe the kit, review the results from the lab, and support women throughout their at-home screening experience.

Teal Health's FDA approval was supported by their SELF-CERV study, the largest US-based comparative study of its kind. The study confirmed that self-collected samples using the Teal Wand have the same performance as clinician-collected samples, proven to detect cervical precancer 96% of the time, and that the Teal Wand is a much preferred experience.

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