Teal Health’s At-Home Cervical Cancer Screening Gets FDA Approval

In a milestone moment for preventive care, Teal Health has received FDA approval for the Teal Wand—the first at-home cervical cancer screening device in the United States. Designed to detect human papillomavirus (HPV), the virus responsible for nearly all cervical cancers, the device offers clinically equivalent results to traditional clinician-collected samples—without requiring a speculum or in-clinic exam.

This approval marks a turning point in how women can manage their reproductive health, offering a screening method that is not only medically accurate but also user-centered, trauma-informed, and accessible from home.

A Quiet Revolution in Cervical Cancer Screening

Targeted at women and individuals aged 25–65 at average risk, the Teal Wand includes both the self-collection device and access to a telehealth platform. Users can complete the test at home, then connect with licensed Teal medical providers for results, support, referrals, and follow-up care.

Teal Health CEO and co-founder Kara Egan, reflecting on the larger significance of the device, said:

“This isn’t just an innovation—it’s liberation. We’re removing the barriers that keep women from putting their health first. A screening method that fits into real life—especially for mothers, caregivers, and busy women—isn’t just nice to have. It’s necessary.”

The impact is significant: over 25% of women in the U.S. are currently behind on cervical cancer screenings, often due to time constraints, discomfort, or systemic barriers to accessing in-clinic care.

Evidence-Based and Women-Backed

FDA approval was driven by data from the SELF-CERV study, the largest U.S.-based comparative study on cervical cancer self-screening. The results speak for themselves:

• 96% accuracy in detecting cervical precancer—on par with samples collected by clinicians

• 94% of participants preferred self-collection with the Teal Wand over in-clinic testing

• 86% said they would be more likely to stay current with screenings if self-testing at home were an option

This isn’t simply a product advancement—it’s a reimagining of healthcare delivery with women’s lived realities at the center.

Trena Depel, Teal Health’s VP of Clinical, Regulatory, and Quality, highlighted the regulatory momentum behind the innovation:

“The FDA recognised the potential impact of at-home self-sampling to close screening gaps, especially in light of the latest USPSTF draft guidelines. That urgency led to Breakthrough Device Designation and, now, full approval for a solution that offers real performance and real choice.”

A Systemic Shift—One Kit at a Time

The kits are expected to begin shipping in June, first in California, with national rollout to follow. Teal Health is partnering with major insurers to ensure coverage and also plans to offer flexible payment options for broader access.

Critically, the integrated telehealth experience offers end-to-end care—supporting users from initial test through to results, guidance, and referrals. This approach aims to address the sobering statistic that nearly 75% of women with abnormal results don’t follow up—often due to lack of clarity or support.

What This Means for The Female Body

For decades, women have been asked to conform to systems designed without them in mind. Teal Health’s FDA-approved solution offers something rare in healthcare: agency, dignity, and convenience, without compromising accuracy. In the fight to close diagnostic gaps, particularly in cancers that are preventable with early detection, this is more than a new device—it’s a necessary shift in who gets to access care, and how.