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

San Francisco, California, United States, 17th Apr 2025 - 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 vagina...

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