Pathogen Transmission in Hospitals Puts Patients & Family Members at Risk; Xenex LightStrike+ Robots Proven to Destroy Deadly Germs on Hospital Surfaces

Xenex LightStrike+ Robots Proven to Destroy Deadly Germs on Hospital Surfaces

SAN ANTONIO, Oct. 8, 2024 /PRNewswire/ -- October is World MRSA Awareness Month, which was created to raise awareness of methicillin-resistant Staphylococcus aureus (MRSA) bacteria and how to prevent its spread. A recent study published in the prestigious journal Infection Control & Hospital Epidemiology (ICHE) underscores the alarming risk of pathogen transmission from hospitals to patients' homes.

FDA Establishes New Medical Device Category

FDA Authorization Now Required to Market UV Robots to Healthcare Facilities

Newswise — The U.S. Food and Drug Administration (“FDA”) has announced a new medical device product classification “whole room microbial reduction device” which establishes FDA regulation of UV robots intended to reduce the number of pathogens in unoccupied patient rooms, operating rooms and other areas in healthcare facilities where non-critical medical devices are present.

FDA Grants Xenex Authorization for LightStrike+ UV Robot via De Novo – First & Only Microbial Reduction Robot for Healthcare Facilities

First & Only Microbial Reduction Robot for Healthcare Facilities

SAN ANTONIO--(BUSINESS WIRE)--The U.S. Food and Drug Administration (“FDA”) has granted Xenex Disinfection Services, Inc. (“Xenex”) De Novo authorization for the company’s LightStrike^TM+ device, a high-intensity, broad-spectrum ultraviolet (UV) light robot. The authorization creates a new medical device product classification under which the LightStrike+ robot is the first and only product of its type, setting the precedent for FDA regulation of UV robots intended for use in reducing pathogens on non-porous, high-touch surfaces in the healthcare environment.

Pathogens in Patient Environments: Reducing Risk Before It Hits Your Bottom Line

It’s no surprise pathogens persist after chemical cleaning – contaminated hospital surfaces have been extensively studied. In fact, a recent...

Honoring Hospital Innovators & Advocates This Thanksgiving

Xenex is extremely grateful for the relationships we’ve built with hospitals and healthcare advocates who have embraced our LightStrike UV...

Understanding the Difference Between FDA Authorization and Emergency Use Authorization for Medical Devices

There is an important difference between FDA Authorization and Emergency Use Authorization (EUA) for medical devices. Coming out of the...