Wingwomen Inc. Announces FDA Exemption for Four Devices from Groundbreaking Vaginal Speculum Patent Attempt

SAN FRANCISCO, CA, UNITED STATES, April 17, 2025 /EINPresswire.com/ -- Wingwomen Inc., the women’s reproductive health start-up founded by doula, and student-midwife Adonica Shaw, proudly announces that four of the eight devices from its original 2023 vaginal speculum patent attempt have been officially exempted by the U.S. Food and Drug Administration (FDA). This critical milestone clears the path for these innovative devices to enter multiple markets in 2025.

Founded in 2021, Wingwomen Inc. was launched with the mission to radically reimagine women’s reproductive care. In 2023, Shaw submitted her first patent application, aiming to redesign the vaginal speculum—a tool that has seen little innovation since its invention in the 1800s. After initial pushback from consultants and advisors who deemed the designs unviable under FDA regulations, Shaw took a bold step in 2024 by open-sourcing feedback on her work.

“After our failed attempt to open a clinic in Boston and being told repeatedly that our designs wouldn't meet FDA standards, we began winding down the company,” said Shaw. “But after creating a digital version of the speculum and winning the FemTech of the Year award from MedTech World in Dubai this February, my mentors encouraged me to go directly to the FDA—without consultants—and do my own diligence.”

Following her submission, the FDA reviewed the original 2023 designs and determined that four of the eight devices qualified for exemption. With support from a private firm, Wingwomen is now preparing for global market entry of these devices.

Each speculum was thoughtfully designed to address a range of patient factors—such as age, BMI, reproductive history, race, and anatomy—offering a more inclusive, comfortable alternative to traditional designs.

Historically, the vaginal speculum has a fraught legacy. It is still widely used today during IVF embryo transfers and cervical cancer screenings, yet its origins trace back to male physicians like James Marion Sims, whose experimentation on enslaved Black women casts a long shadow over the field of gynecology. Shaw’s work aims to both redesign the device and reframe the experience of its use.

“We have the science, the data, and the ethical guardrails to do better by women,” Shaw added. “These designs are the result of lived experience—as both a patient and a care provider. This is a human-centered reimagining of what should have always been a more compassionate and dignified experience.”

About Adonica Shaw
Adonica Shaw is a 4x TEDx speaker, author, doula, student-midwife, and integrative health coach. She serves as a patient advocate with the Preeclampsia Foundation. In parallel, she is the founder and CEO of Wingwomen Companies which are dedicated to improving health outcomes for women and children.

About Wingwomen Inc.
Wingwomen Inc. is a Femhealth company committed to transforming reproductive care through education, advocacy, and human-centered innovation. The company is on a mission to address care gaps and empower women to become active participants in their reproductive health journeys.

For press inquiries, partnerships, or more information, visit www.mywingwomen.com.

Wingwomen Inc.
mywingwomen.com
info@mywingwomen.com

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