FDA clears UVision360 hysteroscopy device

UVision360 said today it won FDA 510(k) clearance for its Luminelle DTx hysteroscopy system, now indicated for both hysteroscopy and cystoscopy.

The Raleigh, N.C.-based company’s Luminelle DTx system is designed to allow physicians to see the internal lining of the uterus from an optimal distance to allow for the identification of suspicious tissue. The system also allows for biopsies to be performed under visualization, UVision said.

“Since the best technology is typically only available in the operating room, many physicians and patients opt to skip the hysteroscopy and either perform a blind biopsy or go straight to surgery, without taking a good look inside of the uterus. An in-office system that is easy to use, prevents a blind biopsy and allows the physician to offer either a therapeutic diagnosis or a biopsy under visualization elevates the standard for uterine care,” Dr. Amy Garcia of Albuquerque’s Center for Women’s Surgery; Institute for Hysteroscopy Training said in a press release.

“Most operating room equipment is cost and space prohibitive for standard office use. We created an elegant and ergonomic system with visualization quality comparable to that of the OR, and that is comfortable for both physician and patient. Our system is a fully-integrated hysteroscopy/cystoscopy system with a value-based cost to provide better accessibility for the changing needs of today’s GYN. The combined features lead to the potential for better care for women, earlier detection, and improved health outcomes,” UVision360 CEO Allison Brown said in a prepared statement.

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