Proa Medical has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its 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 single-use Brella-Spec vaginal speculum provides light necessary to illuminate the field during procedures and examinations.
The sterile vaginal speculum features a unique canopy design incorporating a bright, deep light source, providing a clear and unobstructed view of the vaginal walls and surrounding structures.
Proa Medical has designed the Brella speculum for use of physicians during high-volume procedures in their offices and clinics.
Proa Medical CEO Arman Nadershahi said that 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," Nadershahi added.