Teal Health Receives FDA Approval for At-Home Cervical Cancer Screening Device

On May 9, Teal Health announced it has received FDA approval for the Teal Wand, the first at-home self-collection device for cervical cancer screening in the United States. Designed for women aged 25–65 at average risk, the prescription-based device allows users to collect a vaginal sample from home with the same accuracy as an in-clinic exam.

The Teal Wand will be available through Teal’s website and includes access to a full telehealth service, where medical providers prescribe the kit, review results, and guide users through the screening process.

The approval addresses a significant gap in cervical cancer screening, as over a quarter of women in the U.S. are not up to date with regular testing. Many face barriers such as time constraints, difficulty securing appointments, or discomfort with traditional exams. The Teal Wand offers a science-backed, empathetically designed alternative that makes screening more accessible and convenient, empowering women to prioritize their health on their own terms.

The FDA’s decision was based on data from the SELF-CERV study, the largest U.S.-based study of self-collected cervical samples. It demonstrated that the Teal Wand matched the accuracy of clinician-collected samples, detecting cervical precancer in 96% of cases. The study also found strong user preference, with 94% of participants favoring at-home self-collection if accuracy was assured, and 86% saying it would help them stay up to date with screenings.