Regulator
The FDA cleared the LightStrike+ robot through the De Novo route, creating a new device category for UV robots that reduce germs on hard surfaces in healthcare settings.
A regulator's decision · Company-reported · Sets LightStrike's stage
What the source says
“The authorization creates a new medical device product classification.”
What it means
LightStrike, from Xenex Disinfection Services, is at stage 5 of 5 on our ladder: regulator-cleared or mass market. This event is one of the milestones that placed it there. This line rests on the company's own announcement; no regulator, customer or independent report confirms it in our sources yet.
Human help: Our sources report it working without human help.
More on LightStrike
- Health Canada registered the LightStrike6 robot for sale to healthcare facilities in Canada.
- Xenex said hospitals using LightStrike had completed 44 million cycles.
- Xenex said its robots had run more than 40 million cycles in more than 1,200 hospitals and healthcare sites.
- Xenex raised $38 million in a round led by Essex Woodlands.
- Japanese medical company Terumo agreed to sell LightStrike robots in Japan.