Pivot’s Breath Sensor gets FDA recognition of its ability to help smokers quit

The Pivot Carbon Monoxide Breath Sensor has received expanded FDA approval in recognition that it has the ability to help people quit smoking. This comes in the form of a new 510k clearance that is based on published clinical trial data. It comes on top of an earlier FDA clearance received in 2017.

For those not in the know, the gadget comes from Redwood City, California-based company called Carrot. They’ve developed a whole ecosystem developed to help people quit smoking.

A part of this is the Pivot Breath Sensor – the first over-the-counter FDA-cleared breath sensor for smoking cessation. This means it can be purchased and used without a doctor’s prescription and oversight.

“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.”

Smoking statistics

Smoking is a bad habit – we all know that. Yet it is estimated that around a billion of people around the world enjoy tobacco on a regular basis.

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According to the World Health Organization (WHO) cigarette smoking will eventually end up killing about a half of its users. That equates to around 8 million each and every day, 1.2 million of which are non-smokers breathing in second-hand smoke. It is the greatest health threat the world has ever seen.

Statistics show that this is mostly a problem in underdeveloped countries. They account for 80% of these figures. But the data make grim reading elsewhere, as well.

In the US, for example, cigarette smoking results in 1 out of every 5 deaths, or some 480,000 fatalities per year. The CDC says this is the leading cause of preventable disease, disability and death in the country. Some 50 million people use tobacco in America.

Pivot Breath Sensor

When you smoke, carbon monoxide (CO) is absorbed into your bloodstream. The Pivot Breath Sensor measures these levels in exhaled breath thus quantifying your exposure. To obtain a reading you simply need to blow into the keychain sized sensor.

There is a corresponding app that goes along with it. This keeps tabs on trends, the number or cigarettes smoked, it identifies patterns and helps you build skills to ditch the unhealthy habit.

Over time, hopefully it will show how your levels of CO decline thus serving as a motivational tool. It also lets you know how close your CO levels are to a non-smoker and how much money you have thrown away on the habit. Finally, you get an optional real-world coach to support you on your journey via secure in-app texting.

The effectiveness of the sensor has been demonstrated in clinical trials. One of these was published in the Journal of Medical Internet Research late last year.

It shows that 39% of the 234 heavy smokers participating in the study reduced tobacco use by more than a half in three months. About a half of participants reported at least one quit lasting more than a day. All in all, study participants using the tobacco sensor were much more likely to stop smoking than the control group.

This latest FDA clearance gives recognition that Pivot Breath Sensor goes beyond simply measuring the impact of smoking cessation. It actually helps people kick the habit. The FDA approval gives Carrot the permission to add this to the labelling and marketing of the sensor.

The gizmo can be purchased through a wide range of employers and health plans. Pivot is also be purchased over-the-counter by individuals at carrot.co.

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