mHealth Device Earns FDA Approval to Help Smokers Kick The Habit

The FDA has OK'ed a mobile device that measures a user's CO intake. Combined with an mHealth app, the digital health platform can be used to help smokers kick the habit.

By Eric Wicklund on

A mobile breath sensor has earned federal approval as a class 2 medical device. Combined with a new mHealth app, the digital health platform can now be used to help smokers kick the habit.

The U.S. Food and Drug Administration's 510(k) clerarance of Carrot's OTC breath sensor means the handheld sensor, which measures a user's carbon monoxide intake, can be used with the company's Pivot mHealth app and coaching platform in smoking cessation programs.The sensor evaluates CO levels, which rise when someone smokes, and triggers the app, which delivers targeted messages and information on how to stop smoking.

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“Smoking is the number one cause of preventable illness and death worldwide,” David S. Utley, MD, founder and CEO of the Redwood City, Calif.-based startup, said in a press release. “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 targets the estimated 40 million smokers in the US, of which roughly 500,000 die each year from causes attributed to that habit. Research indicates about 70 percent of smokers want to quit, but only about half try to quit and roughly 12 percent are successful. With in-person counseling, that number rises to between 30 percent and 40 percent.

A growing number of mHealth companies and healthcare providers are taking aim at smoking and other addictions through the smartphone, with the idea that an always-available, real-time resource can improve those odds of successfully kicking the habit.

There is evidence that the mHealth approach can work. Earlier this year, researchers at New York’s Icahn School of Medicine at Mount Sinai and Phoenix-based Translational Research Institute teamed with Click Therapeutics to study how an mHealth app might help smokers who want to kick the habit.

As reported in the Journal of Medical Internet Research, smokers who used Click’s Clickotine app improved their 7-day and 30-day abstinence rates when compared to national averages.

In 2016, a California-based company called Chrono Health, backed by venture capital funds from, among others, the Mayo Clinic and Kaiser Permanente, unveiled a smartpatch that measures a user’s vital signs and releases “biologically timed” medications. The mHealth platform, still in development, pairs with an app that tracks data and offers a coaching platform and connection with care providers.

And in 2015, the Memphis-based Center for Excellence in Mobile Sensor Data-to-Knowledge (MD2K) launched a study, called puffMarker, which uses a wearable and a respiration sensor attached to the chest to determine if someone is smoking. In particular, the study focused on monitoring those who’d quit smoking for relapses.

"Our work opens up a very rich area of research for discovering just-in-time interventions that can be triggered from predictors detected by sensors such as GPS, smart eyeglasses, electronic and social media and physiological sensors," the center's researchers said in a paper presented at the 2015 ACM International Joint Conference on Pervasive and Ubiquitous Computing (UbiComp).

With the nation in the grips of an opioid crisis, mHealth advocates also see apps as an alternative to medication – a view federal authorities may share.

Just last month, the FDA approved what it termed the first “digital therapeutic,” a mobile app for people with substance abuse issues called reSET.

“This is a defining moment for digital therapeutics and for patients with substance use disorder,” Corey McCann, president and CEO of reSET developer Pear Therapeutics, said in a press release. “As the first FDA-cleared Prescription Digital Therapeutic for disease treatment, reSET has demonstrated improved abstinence and treatment retention in a randomized controlled clinical study.”

“We believe that prescription digital therapeutics hold promise in improving patient outcomes across a wide range of central nervous system disorders including psychiatry, neurology, and pain, and will become a vital part of tomorrow’s treatment paradigm across all disease areas,” McCann said.

“This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment,” added Carlos Peña, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder.”

In time, healthcare providers hope to be able to prescribe mHealth apps, platforms and devices instead of drugs to treat everything from addictions and behavioral health issues to pain management.

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