Teal Health®, a women’s health company on a mission to eliminate cervical cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved the Teal Wand™, the first and only at-home self-collection device for cervical cancer screening in the United States.

This landmark approval offers women a new, convenient, and clinically validated alternative to in-clinic Pap smears—allowing self-collection from the comfort and privacy of home. Designed for women ages 25 to 65 at average risk, the Teal Wand™ will be available for direct order at getteal.com, and includes access to Teal’s end-to-end virtual care platform, connecting users with medical providers throughout the screening process.

“The Teal Wand™ is a preferred alternative—built with empathy, backed by science, and designed to make screening easier, so more women can take control of their health on their own terms,” said Kara Egan, CEO and Co-Founder of Teal Health.

Addressing Critical Gaps in Women’s Preventive Health

Cervical cancer is highly preventable through routine screening, yet more than one in four women in the U.S. are overdue. Common barriers include difficulty taking time off work, discomfort with pelvic exams, and limited access to care. The Teal Wand™ aims to remove these obstacles by providing a more accessible, patient-friendly option.

Unlike traditional Pap smears, which have a sensitivity of approximately 55%, the Teal Wand™ is used for primary HPV testing—the preferred screening method per medical guidelines—with a sensitivity rate of 95%. Clinical data show the device is as effective as clinician-collected samples.

Validated by the Largest Study of Its Kind

The FDA’s decision was supported by Teal Health’s pivotal SELF-CERV study, the largest U.S.-based comparative trial evaluating self-collected versus clinician-collected cervical samples. Results confirmed equivalent accuracy, with 94% of participants expressing a preference for at-home screening, and 86% stating they’d be more likely to stay up to date with routine screenings if they could use the Teal Wand™ at home.

Nationwide Launch Begins in June

Teal Health will begin shipping kits in June, starting in California and expanding nationwide. The company is actively working with insurance providers and plans to offer flexible payment options to ensure broad access.

“As a mom and a woman, I understand how easy it is to put your health last. This approval isn’t just about innovation—it’s about giving women a screening option that fits their lives,” said Egan. “When care is easier to access, more women stay healthy—not just for themselves, but for those who count on them.”