Xenex Makes De Novo Petition To FDA For LightStrike UV Room Disinfection Expertise
Xenex Disinfection Providers, the world chief in UV disinfection know-how for healthcare amenities, right this moment introduced it has filed a De Novo petition with the U.S. Meals and Drug Administration (“FDA”) for medical machine market authorization of its LightStrike+ ultraviolet (UV) room disinfection know-how.
The corporate’s patented machine makes use of a xenon lamp to create broad spectrum UV mild supposed to rapidly destroy pathogens on surfaces in healthcare amenities.
Xenex’s LightStrike know-how is at the moment being offered pursuant to an FDA enforcement coverage that was issued to permit mild primarily based disinfection merchandise to be delivered to market through the international pandemic (Enforcement Coverage for Sterilizers, Disinfectant Gadgets, and Air Purifiers Through the Coronavirus Illness 2019 (COVID-19) Public Well being Emergency). The De Novo pathway permits for creation of a wholly new product classification and, if granted, will strengthen Xenex‘s main place within the UV disinfection trade by acquiring FDA authorization to market LightStrike+ (the brand new iteration of the machine) as a medical machine. The submitting consists of substantial knowledge on testing with the machine and leverages the sturdy scientific proof revealed in peer-reviewed articles concerning the efficacy of the LightStrike™ disinfection know-how.
Dangerous microorganisms can stay on surfaces in healthcare amenities, even after the perfect guide cleansing efforts. Most of the world’s main hospitals and well being programs, together with HonorHealth, Mayo Clinic, MD Anderson, Ochsner Well being, and Texas Well being Sources, make the most of LightStrike’s highly effective UV-C disinfection know-how to attain optimum cleanliness by destroying pathogens missed through the guide room cleansing course of. There have been greater than 45 peer-reviewed, revealed research in scientific journals demonstrating the effectiveness of the LightStrike disinfection know-how, which is protected by 193 patents.
“Once we began Xenex, UV room disinfection in healthcare amenities was novel. Over the course of time, proactive hospitals deployed our robots to disinfect their amenities and we’re extraordinarily pleased with the success these hospitals achieved. At the moment, room disinfection with LightStrike robots has turn into commonplace of care in lots of hospitals. The worth and significance of what they’ve completed is such that we’re submitting our De Novo petition to the FDA and we welcome the change within the UV room disinfection trade as a result of it’s that necessary to sufferers and healthcare employees,” stated Dr. Mark “Tuck” Stibich, founder and Chief Scientific Officer of Xenex.
“LightStrike Germ-Zapping Robots have been deployed by greater than 1,000 hospitals worldwide and we’re very proud that these hospitals have safely accomplished greater than 35 million disinfection cycles,” stated Morris Miller, CEO of Xenex. “We’ve got been working intently with the FDA to explain to them our distinctive broad spectrum UV disinfection machine, and we’re very excited to pursue this De Novo classification. Our hospital companions have been in search of readability within the UV room disinfection market and we consider that this can assist them make knowledgeable, evidence-based selections.”
Healthcare professionals try to make hospitals secure and for his or her amenities to be sanctuaries for therapeutic. Guaranteeing a correctly disinfected surroundings is a key a part of that technique. The LightStrike UV robotic emits intense bursts of broad spectrum, pulsed xenon UV mild to destroy pathogens on surfaces and is efficient in opposition to multi-drug resistant organisms present in hospitals, together with methicillin-resistant Staphylococcus aureus (MRSA), Clostridioides difficile (C. diff), and VRE (Vancomycin-resistant Enterococci).