Carrot gets FDA nod for over-the-counter use of smoking cessation device

Carrot received 510(k) clearance to use its Pivot sensor for smoking cessation. It measures carbon monoxide levels in a person’s breath. Photo credit: Carrot

Digital health startup Carrot received the green light from regulators for patients to use its smoking cessation device without physician oversight. The Redwood City, Calif.-based company makes an at-home device, called Pivot, that measures carbon monoxide in a person’s breath, which enters the bloodstream when a person smokes.

Based on this device data, the company has built a digital health program including real-time feedback, text-based coaching and nicotine replacement treatment delivered to patients’ homes. It’s also drummed up partnerships with some health plans, including New York Life and BlueCross BlueShield of North Carolina.

Part of the goal behind the company is to make quitting tobacco more accessible, rather than an intimidating, all-or-nothing process.

The expanded indication was based on a single-arm, open-label study of 234 people who smoke. They used the device for 12 weeks, and filled out questionnaires on their attitudes toward quitting smoking and smoking behavior.

By the end of the study, a little less than half of participants said they intended to quit smoking in the next month, compared to about 15% at the start of the study. About 55% of participants’ motivations remained unchanged, whether or not they intended to quit.

About 48% said they had tried to quit after 12 weeks, and the number of cigarettes consumed per day decreased about 41% from the start of the study.But more rigorous data will be needed to prove that Carrot’s device had a meaningful impact on people’s smoking behaviors over the long term. Some future steps include a randomized, control trial and studies that follow people’s outcomes over the longer term.