FDA approves first cervical cancer screening device that can be used at home, company says
- The FDA approved Teal Health's Teal Wand on May 9, 2025, as the first cervical cancer screening kit for at-home sample collection in the U.S.
- This approval responded to low screening rates, as only one in four women receive regular cervical cancer tests despite CDC guidelines.
- Teal Wand uses a swab inserted into the vagina to collect samples detecting HPV, the virus causing over 99% of cervical cancers, which are mostly sexually transmitted infections.
- The company, based in San Francisco, will first market the prescription-required kit in California starting next month while working with insurers like Aetna to expand access.
- This device may increase screening convenience and coverage, addressing inadequate screening linked to most cervical cancer cases and potentially improving early detection and treatment.
161 Articles
161 Articles
FDA approves at-home pap smear alternative device for cervical cancer screening
The Food and Drug Administration has approved a new device called the Teal Wand, which its creator describes as an "at-home vaginal sample self-collection device for cervical cancer screening." It could be especially useful for women who find pap smears uncomfortable, painful and even traumatic, as well as for those who may not have time to go to a doctor or have disabilities preventing them from traveling to consult one. Users who get the Teal …
FDA approves first home test kit for cervical cancer, says company
U.S. regulators approved the first cervical cancer test kit that allows women to collect their own sample at home before sending it to a lab, according to a medical device company. Teal Health announced on Friday that the Food and Drug Administration (FDA) approved its Teal Wand for domestic use, which offers a new way to collect vaginal samples that can detect the human papillomavirus (HPV), which causes cervical cancer. Currently, HPV tests an…
Skip the Pap? New at-home cervical cancer screening tool approved by FDA but it's not for everyone
There's a new self-guided way to screen for cervical cancer at home that was approved by the FDA. But doctors caution that it's not for everyone. Here's what you need to know.
Coverage Details
Bias Distribution
- 66% of the sources are Center
To view factuality data please Upgrade to Premium
Ownership
To view ownership data please Upgrade to Vantage