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FDA Grants De Novo Authorization to Xenex

by Pieter Werner

The U.S. Food and Drug Administration (FDA) has awarded Xenex Disinfection Services a De Novo authorization for its LightStrike+ device, a robot that employs high-intensity, broad-spectrum ultraviolet (UV) light for disinfection. This authorization ushers in a new category of medical device products, wherein the LightStrike+ robot stands as the inaugural and sole product of this kind, establishing a new standard for FDA regulatory procedures concerning UV robots designated for pathogen reduction on non-porous, frequently touched surfaces in healthcare settings.

Xenex asserts that this FDA approval will provide assurance to hospital administrators regarding the validity and accuracy of the claims associated with the LightStrike+ device. The robots are meant to decrease microbial presence on surfaces of non-critical medical devices in healthcare settings, following conventional cleaning and disinfection processes. The authorization permits the usage of these devices in various healthcare environments such as unoccupied operating and hospital rooms, where non-critical medical devices are found.

Globally, over 1,200 healthcare facilities have utilized LightStrike robots in excess of 37 million cycles. The newly introduced LightStrike+ robot, which can complete a microbial reduction cycle in as little as 2 minutes, is the culmination of over ten years of accumulated experience and best practices in healthcare facilities. This experience is backed by 45 peer-reviewed studies, 193 patents, and a leading position in technical and epidemiological expertise. Notable healthcare facilities such as HonorHealth, Mayo Clinic, and Stanford Health Care have incorporated LightStrike robots into their disinfection strategies.

The LightStrike+ robot uses a xenon lamp to produce high-intensity pulsed UV light that aims to decrease the amount of dangerous pathogens found on surfaces within healthcare facilities, potentially curtailing the transmission chain from individual to individual. The FDA authorization of Xenex’s robot is based on extensive testing conducted on more than 10,000 samples of vegetative bacteria and Clostridioides difficile (C.diff) spores.

Dr. Mark “Tuck” Stibich, Xenex’s founder and Chief Scientific Officer, remarked on the role of the company in aiding hospitals to enhance patient safety and public health over the last decade. He expressed hopes that the FDA authorization would facilitate more hospitals in employing this technology in their efforts to combat pathogens. Moreover, Xenex CEO Morris Miller emphasized that the authorization would bolster confidence among hospital decision-makers regarding the effectiveness of UV technologies, particularly the claims associated with the LightStrike+.

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