Wednesday, September 06, 2023
The U.S. Food and Drug Administration (FDA) has granted Xenex Disinfection Services a De Novo authorization for its LightStrikeTM+ device. This innovative device utilizes high-intensity, broad-spectrum ultraviolet (UV) light to effectively combat pathogens. This FDA approval introduces a new classification for medical devices specifically designed for UV robots aimed at reducing pathogens on high-touch, non-porous surfaces within healthcare settings.
The LightStrike+ robot is the pioneering product within this newly defined category and sets an important precedent for the FDA's oversight of UV robots intended for pathogen reduction on non-critical medical device surfaces in healthcare facilities. These robots are designed for use in various healthcare settings, including unoccupied operating rooms, hospital rooms, and other clinical environments where non-critical medical devices are commonly found.
It's worth noting that more than 1,200 healthcare facilities worldwide have already integrated LightStrike robots into their infection control protocols, totaling over 37 million operational cycles. With a remarkably quick microbial reduction process, sometimes as short as a 2-minute runtime, the LightStrike+ device benefits from over a decade of accumulated knowledge derived from best practices implemented in healthcare facilities
The LightStrike+ robot employs a xenon lamp to generate high-intensity pulsed UV light, significantly reducing the presence of pathogens on surfaces. This groundbreaking technology plays a crucial role in breaking the chain of transmission from one patient or healthcare worker to the next.
The FDA's authorization provides healthcare decision-makers with confidence in the accuracy and effectiveness of the LightStrike+ device, reinforcing its vital role in maintaining clean and safe healthcare environments and promoting patient well-being.
Source: businesswire.com
