How Teal Health Is Expanding Access to Cervical Cancer Screening

At the 2025 LSX World Congress in Boston, MedTech Spotlight Live by Orthogonal featured conversations with leaders advancing medical technology and access to care. Orthogonal’s Randy Horton spoke with Trena Depel , Vice President of Regulatory, Clinical, and Quality at Teal Health , about her company’s mission to make cervical cancer screening more accessible through an at-home, self-collection device paired with telehealth services.

A Mission to Reach Every Woman

Teal Health is dedicated to ensuring that every woman in the United States can be screened for cervical cancer. Despite the availability of Pap smears, one in three women delays or skips screening, leaving about 20 million of the 92 million eligible women unscreened and at risk.

To address this gap, Teal Health developed the first and only FDA-approved at-home self-collection device for cervical cancer screening, supported by telehealth wraparound services that manage prescribing, education, and follow-up.

How Cervical Cancer Screening Has Evolved

Trena explained how the standard of care has changed over time:

• Pap smears, introduced in the 1950s, became an effective early detection tool that dramatically reduced deaths from cervical cancer.
• In the late 1990s, researchers identified HPV as the primary cause of most cervical cancers.
• The first HPV molecular test received FDA approval in 2014, marking another major advance.

Since then, leading medical organizations such as the American Cancer Society and U.S. Preventive Services Task Force have recognized primary HPV testing as the most sensitive method for detecting cervical cancer, superior to Pap smears alone or co-testing.

This scientific shift enables self-collection because HPV testing can be performed using vaginal cells rather than cervical cells, allowing women to collect samples themselves safely and effectively.

A Purpose-Built Device for Home Use

Unlike devices adapted from nasal or flocked swabs, Teal Health’s collection tool is purpose-built for vaginal self-collection and designed specifically for ease of use in the home setting.

Teal’s approach goes beyond developing the device itself. The company combines it with telehealth services, recognizing that many women, especially those in rural or underserved areas, face limited access to OB-GYNs or even primary care providers.

Through telehealth, Teal provides:

• Licensed clinicians to guide patients through the process.
• Educational materials and online resources via the company’s website and portal.
• Multi-channel communication, including chat and virtual consultations.

This combination helps women receive results, education, and care coordination without leaving their homes.

Navigating Regulation and Telehealth Integration

Trena described how Teal worked with the FDA during the development and review process. The company used early pre-submission discussions to clarify that the telehealth workflow supported the device but remained outside the FDA's authority, since it is not a clinical decision-making tool.

While the device itself is FDA-regulated, the telehealth services fall under telemedicine regulations, not FDA oversight. By being transparent early, Teal helped regulators understand how the model supports guideline-based screening while staying within existing rules.

Because Teal was a new player compared with established diagnostic and pharmaceutical companies, maintaining open communication with the FDA helped demonstrate its seriousness, scientific rigor, and alignment with the agency's expectations.

The Impact of De Novo Approval

Teal Health’s de novo approval made it easier for future innovators. The approval established a broad category for at-home collection devices using molecular tests, creating a clear 510(k) pathway for future at-home diagnostic and collection devices.

Trena advised companies developing similar products to use the FDA’s pre-submission process to address questions and concerns early. Doing so helps speed the review process and maintain alignment with agency expectations. She emphasized that the FDA’s goal is not to reject applications, but that it must meet its timelines and companies that engage early can help ensure a smoother path to approval. 

Designing for the At-Home Environment

Trena noted that at-home use changes a device’s risk profile because the environment can’t be controlled. Teal Health conducted extensive safety, usability, and human factors testing to ensure the device was robust and easy to use correctly.

These studies supported Teal’s at-home indication, a feature that other FDA-approved self-collection devices have not yet achieved. Across more than a thousand research and commercial uses, the team has seen no unexpected issues.

Shifting the Perspective on Access and Capability

Trena emphasized that women should be given credit for what they’re capable of doing when given proper tools and information. Bringing screening into the home gives women more control and removes barriers that prevent participation.

The service is recognized as a Grade A preventive health service under the ACA, meaning the screening itself is covered. While insurance coverage for the device and mailing logistics is still in progress, the foundation for widespread access is in place.

Looking Ahead

Trena is speaking at the LSX World Congress about the changing regulatory landscape, a fitting topic for someone helping to redefine how high-quality preventive care reaches patients outside traditional settings.

By combining a purpose-built device, thoughtful telehealth integration, and regulatory transparency, Teal Health is demonstrating how patient-centered innovation can expand access to life-saving screening.

—

Looking to accelerate your FDA-compliant digital ecosystem development by 2-3x?

For 15 years, we've partnered with dozens of clients, including Medtronic, Johnson & Johnson, Google, Novo Nordisk, Tandem Diabetes Care, Transmedics, Oura, Eli Lilly,  and others to build SaMD and connected device solutions. This work has consistently shortened product development life cycles, improved delivery predictability, and created engaging user experiences.

Schedule your call now