Healthcare Analytics

FDA Grants De Novo for Xenex's LightStrike+ UV Robot in Healthcare

FDA De Novo Clears
United States Food and Drug Administration (USFDA) has issued a De Novo authorization to Xenex Disinfection Services, Inc. (Xenex) for its LightStrikeTM+ device, an advanced high-intensity, broad-spectrum ultraviolet (UV) light robot.

The LightStrike+ devices are designed for microbial reduction on non-critical medical device surfaces in healthcare environments, following manual cleaning and disinfection practices. They are authorized for use in various healthcare settings, including unoccupied operating rooms and hospital rooms. These devices have an impressive track record, with over 1,200 healthcare facilities worldwide employing LightStrike robots for over 37 million cycles.

The new LightStrike+ device, capable of microbial reduction in as little as 2 minutes, represents the culmination of over a decade of knowledge accumulation from healthcare facilities' best practices, supported by 45 peer-reviewed studies demonstrating its safety and effectiveness, a portfolio of 193 patents, and unparalleled technical and epidemiological expertise.

Dr. Mark 'Tuck' Stibich, Xenex's Founder and Chief Scientific Officer, emphasized the long-standing collaboration with healthcare partners spanning more than a decade to enhance patient safety and public health.

As an infectious diseases epidemiologist, Dr. Stibich expressed 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.

Perilous pathogens persist on surfaces within healthcare facilities, notwithstanding diligent manual cleaning endeavors. The LightStrike+ robot employs a xenon lamp to generate high-intensity pulsed UV light, which effectively diminishes the presence of these pathogens on surfaces and plays a pivotal role in interrupting the transmission chain from one patient or healthcare worker to another. Xenex's FDA authorization is substantiated by comprehensive testing conducted on more than 10,000 samples of vegetative bacteria and Clostridiodes difficile (C. diff) spores.

This authorization establishes a novel medical device product classification, with the LightStrike+ robot being its inaugural and sole product. It is a landmark in the FDA's regulatory framework for UV robots designed to diminish pathogens on non-porous, frequently touched surfaces within healthcare settings.

Furthermore, Xenex's Chief Executive Officer, Morris Miller, acknowledged the challenges hospitals face when evaluating UV technologies, citing the prevalence of unverified and exaggerated claims by some manufacturers. He underscored the significance of FDA authorization in instilling confidence among hospital decision-makers, assuring them of the accuracy and validation of Xenex's claims regarding the LightStrike+ device.

Numerous world-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 comprehensive disinfection strategies.
 
About Xenex

Xenex is a global leader in pioneering strategies and solutions grounded in UV technology. Its fundamental mission revolves around enabling its partners to safeguard lives and reduce human suffering by eliminating the dangerous microorganisms that cause infections. The company benefits from substantial support from renowned investors, including EW Healthcare Partners, Piper Sandler, Malin Corporation, Battery Ventures, Targeted Technology Fund II, Tectonic Ventures, and RK Ventures.
 

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