UVision360's, a Raleigh, N.C.-based company announced that its Luminelle DTx hysteroscopy system used for performing both hysteroscopy and cystoscopy won FDA clearance for sale in the US.
The Luminelle DTx Hysteroscopy System is simplified, easy to navigate, fully integrated hysteroscopy system designed for benefits for patients and physician alike.
It enables the physician to perform diagnostic and operative procedures in the office with 75% less investment as compared to traditional endoscopy tower systems. Patients can rip the benefits of faster procedural and recovery time along with cost savings.
The system features a two-part single-use protective sheath consisting of the introducer and 360° Rotating sheath. The introducer thoroughly covers the scope thereby protecting it against bodily fluid and reducing contamination to the minimum. It also separates the inflow and outflow channels to manage the irrigation fluids. The operative channel enables biopsies and polypectomies under direct visualization.
The 360° Rotating sheath facilitates ease of movements and 360° view of the uterine cavity. The flexible 2.0 mm scope is equipped with the latest CMOS micro-technology for a high resolution, high definition view of the inside of uterus and bladder to a depth of 45-55 mm. Specially designed visualization software comes with auto-adjusting lighting for more comfortable viewing of cavities. The whole procedure can be monitored via HDMI or USB 3 for PC or Mac systems, making use of systems already existing in the office.
Dr. Amy Garcia, MD FACOG; Director – Center for Women's Surgery; Institute for Hysteroscopy Training, Albuquerque, NM explains, "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."
Allison London Brown, CEO of UVision360 said in a news 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," she further added.
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