Teal Health Seeks FDA OK for At-Home Cervical Cancer Screening Wand

It offers a more private option for women and people with a cervix.

Teal Wand Box Phone 6 Arrived 3
Teal Health

Teal Health said it has submitted to the FDA its Teal Wand, an at-home cervical cancer screening device designed to give women and people with a cervix a more private method for screening.

After receiving FDA Breakthrough Device Designation earlier this year, the company is now moving toward a full commercial launch for the Teal Wand. The application follows a recent clinical trial, which the company said showed strong performance and a preference for the Teal Wand.

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"Our goal has always been to design for women, listening to their needs and building a solution that fits into their lives. This submission is our final step in being able to deliver that solution," said Kara Egan, CEO of Teal Health. "Cervical cancer is almost entirely preventable when caught early, yet 1 in 4 women in the U.S. are behind on their screenings. Women want to be up-to-date, but the universal truth is that we are just too busy: too busy with our jobs, caring for our kids, helping our aging parents, you name it, we're doing it. The Teal Wand is designed to fit into her schedule, offering a convenient at-home alternative that can allow women to feel supported when taking control of their health."

The Teal Wand is designed to allow users to collect their own vaginal sample at home. The company said all study participants were able to collect a sample, 92% of study participants collected in under two minutes and 90% reported it was as comfortable or more comfortable than the current experience. The study validated the performance of the Teal Wand by comparing results to a clinician-collected sample with a speculum and brush.

"Our study was designed with a commitment to enroll participants who reflect the diversity of the U.S. population and ensure a safe and easy experience," said Trena Depel, Vice President of Clinical and Regulatory at Teal Health. "We credit our clinical study partners for helping support that commitment."

Teal Health's FDA submission comes on the heels of another major milestone. The company announced last week that they have been awarded a $1.68 million SBIR grant from the National Cancer Institute, which will further accelerate the development of the Teal Wand. This funding, along with their submission, marks a major step toward Teal Health's mission to make cervical cancer screening more accessible, ultimately contributing to the eradication of cervical cancer in the U.S. Since its launch, the company has stayed focused on this bold vision. With the overwhelming support of women nationwide, strong clinical data, and this grant, the company is confident that the Teal Wand will play a pivotal role in achieving that goal.

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