FDA 510(k) Clearance for Single-Use Brella-Spec™ Vaginal Speculum

Proa® Medical, Inc., developer of innovative and practical medical devices for women’s health, says it has received U.S. FDA 510(k) clearance to market its single-use device, the Brella-Spec™ Vaginal Speculum.

Background

Los Angeles-based Proa Medical was spawned by USC’s Alfred Mann Institute of Biomedical Engineering in order to assemble a portfolio of innovations by USC-related physicians and quickly develop and commercialize them. These are technologies that are not “big” enough to warrant a company of their own, but have real, practice-enhancing benefits.

The Brella-Spec Vaginal Speculum is designed for visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations. It’s built in light source provides illumination of 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.

Company comments

“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.”

Source: Proa Medical, Inc.

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