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Smoking Cessation

FDA Clears First OTC Carbon Monoxide Breath Sensor For Use In Smoking Cessation Programs

May 19, 2022
By Pivot

Carrot Inc.’s* Bluetooth-enabled mobile device helps users learn how smoking affects their carbon monoxide levels

REDWOOD CITY, Calif., October 3, 2017 — Carrot Inc. announced today that its Carbon Monoxide Breath Sensor System has been cleared by the U.S. Food and Drug Administration (FDA) for over-the-counter (OTC) commercial use in smoking cessation programs. The Bluetooth-enabled mobile device, which pairs to a breath sensor application on a smartphone, measures carbon monoxide in exhaled breath to inform the user about how breath carbon monoxide levels are affected by smoking behavior. As with fitness wearables for tracking metrics like steps and sleep, the breath sensor enables a user to track the real-time effects of their smoking behavior.

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“Smoking is the number one cause of preventable illness and death worldwide,” 1 said David S. Utley, M.D., founder and CEO of Carrot Inc., a digital health company with a mission to engage and empower millions of people to quit smoking. “While there has been a torrent of wearable tech to facilitate behavior change in fitness, weight loss and other targets, there’s been no such innovation to help people quit smoking. So, we’ve designed a home-use mobile breath sensor device to help people who smoke cigarettes learn about their smoking behavior, and to use this information to help them in smoking cessation programs.”

Carrot’s announcement of FDA 510(k) clearance of its OTC breath sensor coincides with the launch of Pivot, Carrot’s new smoking cessation program, delivered as a mobile medical application via a smartphone. Pivot, which offers evidence-based motivational, educational and coaching tools, will initially be offered through self-insured U.S. employers to promote healthy workplaces and to reduce lost productivity and excess healthcare costs associated with smoking.Despite the fact that 70 percent of smokers say they want to quit, less than seven percent of eligible smokers sign up for workplace cessation programs – even when they’re free,”1,2 said Heather Patrick, Ph. D., vice president of behavioral science at Carrot. “Part of the reason for that is that most programs start with setting a quit date, then go straight to creating a quit plan. That’s intimidating. So, Pivot has entirely reimagined smoking cessation, first by designing a program that is for all smokers, not just those ready to quit. And, second, by delivering evidence-based behavioral science strategies directly to the participant via their smartphone. Pivot is designed to appeal to and help smokers no matter where they are in their quit journey.”Smoking remains the leading cause of preventable illness and death in the U.S., where 40 million people smoke and nearly 500,000 die every year from smoking-related illness.1,3 Smoking is an enormous drag on the U.S. economy, with more than $300 billion in related healthcare costs and lost productivity annually.4

About Carrot Inc. (
Carrot is a digital health company based in Redwood City, California, backed by Khosla Ventures, Salesforce founder Marc Benioff, Chicago-based R7 Partners and David Utley, M.D. The company was founded by Utley, a former head and neck cancer surgeon (Stanford) and medical device entrepreneur (BARRX, Covidien), with the goal of using technology and behavioral science to address the world’s largest public health crisis – smoking.1

About Carrot’s Carbon Monoxide Breath Sensor System
The Carbon Monoxide Breath Sensor System (COBSS) is a breath carbon monoxide monitor intended for single-user use by cigarette smokers in smoking cessation programs to inform the user about how breath carbon monoxide levels are affected by smoking behavior. The device is not intended to be used with other inhaled products.

About Pivot (
Pivot is a six-stage, 58-week smoking cessation program, delivered as a mobile medical application via a smartphone. Pivot includes evidence-based quit strategies, motivational interviewing, cognitive behavioral therapy, pharmacologic education and dedicated in-app human coaching. It is for all smokers, regardless of their immediate interest in quitting smoking. Pivot is designed to help smokers develop motivation and confidence to quit, and when ready, assists them through the quit attempt with long-term support.


  1. Centers for Disease Control and Prevention. “Smoking and Tobacco Use: Fast Facts.” 2017. Available from: Last accessed September 29, 2017.
  2. Rand Corporation. Rand Workplace Wellness Programs Study Available from: Last accessed September 29, 2017.
  3. Prochaska JJ, Benowitz NL. “The Past, Present, and Future of Nicotine Addiction Therapy.” Annu. Rev. Med. 2016. 67:467–86.
  4. Centers for Disease Control and Prevention. “Economic Trends in Tobacco.” 2014. Available from: Last accessed September 29, 2017.

Media Contact

Laura Metzger

Upright Position Communications

Tel: +1-339-788-0128

Email: [email protected]

*Pivot Health Technologies Inc. was previously known as Carrot Inc. and changed names in 2022.

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