The United States Food and Drug Administration (FDA) has granted a De Novo authorization to Xenex Disinfection Services, Inc. (Xenex) for its LightStrikeTM+ device, a high-intensity, broad-spectrum ultraviolet (UV) light robot.
LightStrike+ devices are designed for microbial reduction on non-critical medical device surfaces in healthcare environments. They are authorized for use in various healthcare settings, including unoccupied operating rooms and hospital rooms. Over 1,200 healthcare facilities worldwide use LightStrike robots for over 37 million cycles.
The new LightStrike+ device is capable of microbial reduction in as little as 2 minutes. It is the result of more than a decade of knowledge accumulation and collaboration with healthcare partners, supported by 45 peer-reviewed studies, a portfolio of 193 patents, and technical and epidemiological expertise.
Dr. Mark ‘Tuck’ Stibich, Xenex’s Founder and Chief Scientific Officer, emphasized the concern about antibiotic resistance within hospital environments and the potential for FDA authorization to facilitate the broader adoption of the LightStrike+ tool in combating pathogens.
The LightStrike+ robot uses a xenon lamp to generate high-intensity pulsed UV light, effectively reducing the presence of pathogens on surfaces in healthcare settings. The FDA authorization establishes a novel medical device product classification, with the LightStrike+ robot being its inaugural and sole product.
Xenex’s Chief Executive Officer, Morris Miller, emphasized the importance of FDA authorization in instilling confidence among hospital decision-makers about the accuracy and validation of Xenex’s claims regarding the LightStrike+ device.
Renowned hospitals, such as HonorHealth, Mayo Clinic, MD Anderson Cancer Center, Ochsner Health System, Stanford Health Care, and Texas Health Resources, have integrated LightStrike robots into their disinfection strategies.
Xenex focuses on pioneering UV technology-based strategies and solutions to eliminate dangerous microorganisms that cause infections and improve patient safety. The company is supported by various renowned investors.
