Xenex Petitions FDA to Certify its LightStrike UV Room Disinfection Technology
Xenex Disinfection Services, which develops UV disinfection technology for healthcare facilities, announced it has filed a De Novo petition with the U.S. Food and Drug Administration (FDA) for medical device market authorization of its LightStrike+ ultraviolet (UV) room disinfection technology. The company’s patented device emits intense bursts of broad spectrum, pulsed xenon UV light to destroy pathogens on surfaces and is effective against multi-drug resistant organisms found in hospitals, including methicillin-resistant Staphylococcus aureus (MRSA), Clostridioides difficile (C. diff), and VRE (Vancomycin-resistant Enterococci).
Xenex said its LightStrike technology is currently being sold pursuant to an FDA enforcement policy that was issued to allow light-based disinfection products to be brought to market during the global pandemic (Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency). The De Novo pathway allows for creation of a new product classification and, if granted, will strengthen Xenex‘s position in the UV disinfection industry, the company said. The filing includes data on testing with the device and leverages scientific evidence published in peer-reviewed articles about the efficacy of the LightStrike disinfection technology, Xenex added.
Harmful microorganisms can remain on surfaces in healthcare facilities, even after the best manual cleaning efforts. Many of the world’s leading hospitals and health systems, including HonorHealth, Mayo Clinic, MD Anderson, Ochsner Health, and Texas Health Resources, utilize LightStrike’s powerful UV-C disinfection technology to achieve optimal cleanliness by destroying pathogens missed during the manual room cleaning process. There have been more than 45 peer-reviewed, published studies in scientific journals demonstrating the effectiveness of the LightStrike disinfection technology, which is protected by 193 patents, the company said.
“When we started Xenex, UV room disinfection in healthcare facilities was novel,” said Dr. Mark Stibich, founder and chief scientific officer at Xenex. “Over the course of time, proactive hospitals deployed our robots to disinfect their facilities and we’re extremely proud of the success those hospitals achieved. Today, room disinfection with LightStrike robots has become standard of care in many hospitals. The value and importance of what they’ve accomplished is such that we are submitting our De Novo petition to the FDA and we welcome the change in the UV room disinfection industry because it’s that important to patients and healthcare workers.”
“LightStrike Germ-Zapping Robots have been deployed by more than 1,000 hospitals worldwide and we’re very proud that those hospitals have safely completed more than 35 million disinfection cycles,” added Morris Miller, CEO of Xenex.
To learn more, visit the Xenex website here.
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