Beddr's SleepTuner is an FDA-registered sleep tracker that uses SpO2

Goofy but useful

Over the past year, every wearable company under the sun has been charging toward providing better sleep tracking - and Fitbit has thus far been leading the charge.

Beddr's new SleepTuner is taking things off the wrist and onto your forehead. It's about the size of a postage stamp and as heavy as a nickel, and can measure a handful of metrics while you sleep.

Read this: The best sleep trackers and monitors

It's got a 3-axis accelerometer and optical sensors that can sense your heart rate, blood oxygen level, stopped breathing events, sleeping position, movement and awakenings.

The company says all this data is securely stored in Beddr Cloud until it can sync with your phone via Bluetooth. The app will help you build out your tracking night-by-night, and there's even tuning that'll help you calibrate your sleep over the course of a week.

Once you do that, it can show you your trends, from your overall sleep quality to night-to-night improvements in oxygen saturation, stopped breathing events and sleep position. You can even self-report hygiene information in the app to help the information be more tuned to you.

As for how you wear the SleepTuner, it sticks to your forehead via a hypoallergenic disposable adhesive. It's supposed to last multiple nights, and there are 12 adhesives that come with the SleepTuner. Sticking the SleepTuner on your forehead may look goofy, but it's there for three reasons, Beddr CEO and co-founder Mike Kisch tells me.

Beddr's SleepTuner is an FDA-registered sleep tracker that uses SpO2

It's more comfortable than wrist-based trackers, it's a better spot for detecting SpO2 than the wrist and it's a better spot to track sleep position, which is a major indicator of breathing problems while sleeping. "Apnea is very positionally dependent," he says. "People who sleep on their side, on average, have 50% fewer stopped breathing events just by sleeping on their side."

Beddr says a study conducted by the University of California San Francisco's Hypoxia Lab found that its SpO2 sensing had a margin of error of +/- 2.2% when compared with an arterial blood draw. That's within the FDA's allowable error margin of +/- 3.5%.

Speaking of the FDA, the SleepTuner isn't FDA approved, but it is FDA registered. Kisch says the FDA has become more lenient, and is allowing companies to bring health tech products to market quicker without FDA approval - as long as they put in the work for possible surprise inspections.

"What it means is that we don't need to get their approval, we just need to provide all of the necessary information that an approval would normally require in the case that they want to inspect our product or inspect the manufacturing line," he says.


In the first or second quarter of 2019, Beddr plans to use the SleepTuner as a home sleep test diagnostic. It has more work to do, especially with the FDA, but Kisch says the ultimate goal is to turn the SleepTuner into a home sleep test diagnostic.

"Our ambition is that a person will take us into the home, they'll use this and then the data that's captured on this device - a remote sleep physician will look at this data and feel comfortable diagnosing if a person has a sleep disorder or they don't. And then actually prescribing based on the data gathered from our product," he says.

The SleepTuner is available now for $149. You'll get the sensor, 12 adhesives to stick to your forehead, a charging cable and a protective case so you can carry around your wearable should you need to travel.

Beddr's SleepTuner is an FDA-registered sleep tracker that uses SpO2


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