FDA Clears Device for Hysteroscopy and Cystoscopy

The US Food and Drug Administration (FDA) has cleared UVision360's Luminelle DTx Hysteroscopy System for a dual-indication including hysteroscopy and cystoscopy.

The device is small and importantly, can be used by a doctor outside of an operating room to perform a hysteroscopy or cystoscopy. About 76% of hysteroscopy procedures occur in operating rooms, but the Luminelle DTx Hysteroscopy System gives physicians the ability to clearly see the uterus’ internal lining in-office.

"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," explains Amy Garcia, MD FACOG; Director — Center for Women's Surgery; Institute for Hysteroscopy Training, Albuquerque, NM, in a statement. "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."

Physicians using the Luminelle DTx Hysteroscopy System can identify suspicious tissue, perform a biopsy under visualization, and potentially offer a faster diagnosis, treatment, and recovery time.

"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," explains Allison London Brown, CEO of UVision360, the medical device company responsible for the rapid design and launch of the device.

The Luminelle DTx Hysteroscopy System was developed “from concept to commercialization” in just over 2 years’ time according to the company press release, but information on the system’s availability is not yet listed on the company website.

"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,” added London Brown. “The combined features lead to the potential for better care for women, earlier detection, and improved health outcomes."