Proa Medical Receives 510(k) Clearance from FDA for Brella-Spec Vaginal Speculum for Gynecological and Obstetrical Procedures

Proa Medical, Inc., developer of innovative and practical medical devices for women’s health, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its single-use device, the Brella-Spec™ Vaginal Speculum, for visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations. The Brella-Spec Vaginal Speculum provides the light necessary to illuminate the field during procedures and examinations.

The 510(k) clearance of the Brella-Spec Vaginal Speculum follows the market launch of the original Brella Vaginal Retractor, a single-use device with a built-in light source designed to provide optimal visualization and access during vaginal or perineal wound repair. Both sterile devices feature a unique canopy design incorporating a bright, deep light source, providing a clear and unobstructed view of the vaginal walls and surrounding structures.

The original Brella Vaginal Retractor is used in a hospital’s labor and delivery department for hands-free retraction and deep illumination, while the new Brella speculum version of the device was prompted by numerous physician requests to use the Brella during high-volume procedures in their offices and clinics.

“In clinical practice today, doctors come up with great ideas that may not be ‘big’ enough to justify creating a new company, but which have tremendous clinical value to enhance a procedure and its outcomes. Our company concept is simple – to serve as a channel to help these physician-inventors rapidly develop and commercialize their innovative, relatively quick-to-market, ideas in order to enhance clinical practice,” said Arman Nadershahi, Chief Executive Officer of Proa Medical.

“The Brella device is one such simple, but effective, improvement – it provides unobstructed access to the vaginal walls without staff assistance, along with hassle-free, direct illumination of the repair site. This solves the current clinical problem of obstructive retractors and external positioning of a light source,” he continued. “We have a pipeline of such devices in development – like Brella – that have the potential to significantly improve existing procedures to the benefit of patients.”