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FDA greenlights first at-home cervical cancer screening device

May 14, 2025

FDA has approved Teal Health’s Teal Wand, the first at-home self-collection device for cervical cancer screening in the U.S. The approval follows the SELF-Collection for CERVical Cancer Screening (SELF-CERV) study that found at-home screening was as effective as that done in a physician’s office.

Designed for women aged 25 to 65 at average risk, the prescription-only device enables users to collect a vaginal sample at home—no speculum required—and mail it to a certified lab for HPV testing using the same cobas HPV assay used in clinics. The device is paired with a telehealth platform that provides virtual access to prescribing providers, result interpretation, and follow-up support.

The company says the test addresses key barriers to screening, including discomfort, scheduling challenges, and access disparities. The Teal Wand is expected to be available soon via getteal.com.

Sources:

(2025, May 9). Teal Health. FDA Approves Teal Health's Teal Wand™—The First and Only At-Home Self-Collection Device for Cervical Cancer Screening, Introducing a Comfortable Alternative to In-Person Screening. [News release]. https://www.getteal.com/news/fda-approves-teal-healths-teal-wand-tm---the-first-and-only-at-home-self-collection-device-for-cervical-cancer-screening-introducing-a-comfortable-alternative-to-in-person-screening

Ludden, J. (2025, May 10). NPR. The FDA approves first U.S. at-home tool as a Pap-smear alternative. https://www.npr.org/2025/05/10/nx-s1-5394446/fda-cervical-cancer-screening-at-home-tool-pap-smear