From Pittsburgh, Ovala, Inc. makes Revive, an FDA-cleared reusable bladder-support device for women experiencing light leaks during movement, coughing, or exercise. The internally worn support is designed for up to 12 hours of use and can be washed and reused for as many as 31 days, offering an alternative to bulky disposable pads. Ovala also supplies replacement strings to keep the device ready for daily use.
FDA Cleared for Over-the-Counter Use
FDACLEARANCE
Quality certification
FEMSelectFEMSelect develops women’s-health medical devices for pelvic floor conditions, notably EnPlace, a mesh-free system for minimally invasive, same-day pelvic organ prolapse repair. The company grew from POP Medical Solutions, which began developing the technology in 2013, received FDA clearance in 2016, and changed its name to FEMSelect in 2019. FEMSelect is woman-led and also offers FDA-cleared Elitone devices for at-home urinary-incontinence treatment.MANHATTAN, NY
Escala MedicalEscala Medical develops women’s-health devices for pelvic organ prolapse, led by its Mendit system for incision-free pelvic-floor repair in an outpatient setting. Founded to provide advanced repair solutions for POP, the company brings together medical-device and urogynecology experience across its leadership and board. Mendit is FDA-cleared in the United States and is designed to complete repair within minutes, with patients returning to normal activity within a day.BETHLEHEM, PA
YarlapCo-founded by daughter MaryEllen Reider and her father Brent, Yarlap makes an FDA-cleared pelvic-floor exercise device designed to perform Kegel workouts for women. The USA-based company combines Brent’s bio-mimicry electrostimulation expertise with MaryEllen’s focus on accessible, stigma-free pelvic-floor wellness, and its device is manufactured in Ireland.OXFORD, OH
Foxhole LLCFounded around Dr. Faith Leibman’s experience working with disabled Veterans, Foxhole LLC makes The Orchid, a patented funnel-shaped device designed to make urine sample collection for women cleaner and less stressful. The device was developed with Utah State University’s Splash Lab after researchers studied splashback and fluid behavior, and it uses an FDA-approved silicone design that can be sanitized by gamma rays. Foxhole is also identified with woman-owned and service-disabled veteran-owned business certifications.PENN VALLEY, PA