The New Breathalyzer for Keto Dieters
Keyto says it analyzes your breath to tell you how much fat you’re burning. But does it actually work?
At a glance, the palm-sized breathalyzer could easily be mistaken for a vaping pen. But Keyto, a handheld breath sensor with an accompanying mobile app that announced its retail launch earlier this month, isn’t designed for partiers. Instead, it’s a diet-tracking device for disciples of keto, a restrictive low-carb, high-fat diet that drives the dieter’s body into a metabolic state of ketosis, during which the body burns fat for fuel rather than carbohydrates.
Keyto co-founder and CEO Dr. Ray Wu, a former vice president of product management at Weight Watchers, also claims that it’s the most accurate device of its kind on the market.
“It’s a really great mechanism for getting feedback on your food choices,” says Wu. “You breathe into the device and the app will tell you your keto level in real time, seconds later.”
The company, which sells its breath sensors for $99, raised more than $1 million and pre-sold 12,000 devices during the Indiegogo campaign it launched in December. Keyto is part of a wave of so-called digital wellness services that have proliferated in recent years, including meditation, ancestry, and fertility apps.
And no one is regulating them. Of course, that’s no accident.
“Active FDA oversight would provide little to no public health value while unnecessarily delaying patient access to potentially beneficial technologies,” Dr. Scott Gottlieb, then-head of the Food and Drug Administration, wrote in an op-ed on medical app regulation that he co-authored in JAMA last year. In other words, Gottlieb believes regulation would slow down and hinder innovation.
In 2016, the FDA codified its hands-off framework in a guidance it issued on mobile health, which was part of the 21st Century Cures Act, a law intended to speed up the development of innovative medical products.
An FDA official reached by OneZero explained that, similar to medical devices, if an app carries a low risk to patients — the digital equivalent of a toothbrush or a Q-tip — the FDA doesn’t get involved. Higher-risk apps — the digital…
