Carrot’s Smoking Cessation Sensor Gets FDA 510(k) Clearance

July 15, 2021

Redwood City, Calif.-based digital health company Carrot received a 510(k) clearance from the FDA for its Pivot Carbon Monoxide Breath Sensor used to help tobacco smokers quit.

The breath sensor, which is available over the counter, shows users how their tobacco use impacts their carbon monoxide levels.

In a clinical trial in 234 heavy tobacco users, the number of participants who were ready to quit smoking more than tripled in the course of the study, from 15 percent to 48 percent, the company said.

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