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.”

The tool connects to a corresponding app, which can provide insights about the carbon monoxide levels in their body over time and let the user compare their levels to that of a nonsmoker. Pivot users are assigned a coach, and users are able to share their carbon monoxide levels with that coach to facilitate conversations around smoking patterns.

A user's app dashboard includes a snapshot of their daily readings, including the current CO score, the progress of the CO score, the number of cigarettes they have smoked and how much money they have spent on the habit.

Carrot published results of a clinical trial that used the sensor and app in JMIR in October 2020, which found that participants using the program were more motivated to cut down on smoking than those in the control group. 

WHY IT MATTERS

Smoking is still fairly common in the United States. According to the CDC, in 2019, 14% of adults in the U.S. were currently smoking cigarettes. The number of smokers has dropped since 2005, when 20.9% of U.S. adults reported smoking.

Men are more likely to smoke than women, and individuals with less education are more likely to smoke than their peers with higher levels of education.

According to the agency, cigarette smoking is the leading cause of preventable disease, disability and death in the United States.

THE LARGER TREND

This isn't Carrot's first FDA designation. In 2017, the Redwood City, California-based company landed FDA clearance for its Carbon Monoxide Breath Sensor. Since then, the company scored $25 million in funding in an investment round led by Johnson & Johnson Innovation (JJDC).

In 2019, the company published clinical trial results in JMIR mHealth and uHealth that demonstrated nearly a third of enrollees using its program had quit by the end of the program.  

But Carrot isn't the only digital health company looking to help people quit smoking. Quit Genius is another brand looking to help people quit. In 2020, the company also published results in JMIR Mental Health that indicated that participants using the program were more likely to quit smoking than their peers in the control group.

In 2020, the World Health Organization announced a smoking-cessation program that combines free nicotine-replacement therapies with an artificial intelligence-based virtual health worker.

The FDA has even co-sponsored an anti-smoking awareness campaign that includes free-to-play horror-themed video games for teens.

Direct-to-consumer virtual care company Ro expanded into the smoking cessation space in 2018 with the launch of its platform, Zero.