FDA clears Carrot's smoking cessation sensor to be used without doctor oversight

Digital smoking-cessation company Carrot has landed an FDA expanded use indication in a new 510(k) clearance for its connected breath sensor that can detect a user's exposure to cigarette smoke. The new indication allows the tool, called the Pivot Carbon Monoxide Breath Sensor, to be purchased over the counter and used without the oversight of a doctor. Users can blow into the fob-sized sensor to get a reading of their carbon monoxide level. "This is a significant breakthrough in smoking cessation," Dr. David S. Utley, Carrot CEO, said in a statement. "The emergence of an over-the-counter breath sensor that can help people quit tobacco is comparable to when consumer-grade glucose meters became available, empowering people in their own diabetes care."