Carrot gets FDA clearance for OTC breathalyzer for smokers, launches cessation app

By Dave Muoio
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Redwood City, California-based Carrot has received FDA 510(k) clearance for its Carbon Monoxide Breath Sensor System, an over-the-counter, Bluetooth-enabled device that pairs with a smartphone app and is intended for commercial use in smoking cessation programs.

“Smoking is the number one cause of preventable illness and death worldwide,” Dr. David S. Utley, founder and CEO of Carrot, said in a statement. “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 device is intended for a single user to monitor their breath carbon monoxide levels and see how these are affected by their smoking behaviors. The device works alongside Carrot’s newly launched medical mobile app for smoking cessation, Pivot.

The app, according to Carrot, is designed to foster the motivation for smokers to quit and provide long-term support. It includes a six-stage, 58-week smoking cessation program backed by cognitive behavioral therapy, pharmacologic education, and dedicated in-app human coaches. The company said in the statement that it will be initially offering its service through self-employed US employers.

"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," Heather Patrick, vice president of behavioral science at Carrot, said in a statement. "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.”

Digital smoking cessation tools have taken several forms over the years. Apps with various approaches are plentiful; 2Morrow, for instance, teamed up with GlaxoSmithKline last year to offer nicotine patches to users of the company’s SmartQuit smoking cessation app. Hayward, California-based Chrono Therapeutics produces a smartphone-connected drug deliver device that has been validated for nicotine replacement therapy, while Redwood City, California-based startup MindCotine launched a successful Kickstarter campaign in June for a VR smoking cessation program that incorporates mindfulness, biofeedback, immersion, and other psychological techniques.