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.

Xenex Announces World’s First Digital Tracking System

New Device Lets Hospitals Instantly Track & Report Cleaning Events

SAN ANTONIO--(BUSINESS WIRE)--Portable Medical Equipment (PME) such as IV pumps, workstations on wheels (WOWs), and vitals machines can carry and transfer dangerous pathogens between rooms and patients within healthcare facilities because the equipment is often used and rolled between multiple patient rooms. Recognizing the importance of being able to track and report cleaning events, Xenex Disinfection Services today announced TrackMate™, a patented device developed by hospitals for hospitals that provides automated tracking of cleaning events for PME and hospital rooms.

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