The FDA’s approval of Teal Health’s Teal Wand™ marks a major breakthrough in women’s healthcare, as it becomes the first and only at-home self-collection device for cervical cancer screening in the United States. This innovation allows women aged 25–65 at average risk to collect vaginal samples for HPV testing—the primary screening method for cervical cancer—from the comfort and privacy of their homes. By offering an equally accurate alternative to traditional in-clinic Pap smears, the Teal Wand eliminates key barriers such as discomfort, scheduling challenges, and limited access to care, especially for underserved populations.

Cervical cancer is one of the most preventable cancers, yet screening adherence remains low, with over 25% of U.S. women falling behind. The Teal Wand addresses this gap with a user-friendly, science-backed design that has shown high accuracy in detecting cervical precancer (96%) and has been overwhelmingly preferred by women in clinical studies. Its approval was supported by the largest U.S.-based comparative study (SELF-CERV), which validated both its clinical effectiveness and its appeal across diverse racial, ethnic, and socioeconomic groups. These results highlight the device’s potential to significantly increase screening rates and early detection.

With nationwide rollout planned beginning June, Teal Health is also establishing partnerships with insurance providers and offering telehealth support to make the at-home experience seamless and affordable. This FDA approval is more than just regulatory recognition—it is a transformative step in making women’s healthcare more accessible, comfortable, and equitable, empowering more women to take control of their health and ultimately reducing the incidence of cervical cancer across the country.