Xenex’s microbial reduction LightStrike+ UV Robot is granted FDA authorisation marking a new classification type for UV medical devices.
Ultraviolet (UV) disinfecting solution provider, Xenex Disinfection Services has been granted De Novo authorisation from the US Food & Drug Administration (FDA) for its UV robot LightStrike+.
The latest authorisation has created a new medical device classification, with LightStrike+ being the first device to receive this label. The device authorisation was supported by tests performed on over 10,000 samples of vegetative bacteria and Clostridiodes difficile (C.diff) spores.
The classification will now be used as an example for FDA regulation of UV robots in the healthcare industry.
The device uses a xenon lamp to produce high-intensity pulsed UV light to erase the number of pathogens left on surfaces to reduce the risk of infection to patients. It’s currently used in over 1200 medical facilities including HonorHealth, Mayo Clinic, MD Anderson Cancer Centre and more.
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Discussing the company’s collaboration with medical facilities and the FDA authorisation Dr. Mark Stibich, founder, and chief scientific officer of Xenex said: “We have been working with our hospital partners for over a decade to support them in their mission to improve patient safety and public health. As an infectious disease epidemiologist, I am highly concerned about antibiotic resistance in the hospital environment. I hope that FDA authorization will allow hospitals to more easily use this tool in their fight against pathogens,”
