Beddr’s FDA-registered sleep tracker is designed to help you catch more ZZZ’s
Health technology company Beddr has unveiled today SleepTuner – an FDA-registered consumer wearable designed to help you catch more ZZZ’s.
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Weighing only 5 grams, the rather odd looking, postage-sized gizmo attaches to your forehead using a hypoallergenic disposable adhesive. From there the wearable uses optical sensors (with red infrared light) and a 3-axis accelerometer to measure a wealth of stats. This includes blood oxygen (SpO2), heart rate, sleep position and stopped breathing events.
Now you may be wondering why you’re meant to stick it to your forehead. It is a rather odd way to go about things. The company says that this is a proven, clinically valid location for an optical sensor. It ensures that blood oxygen and heart rate data readings are as accurate as possible and allows for the continuous capture of sleep position.
The wearable has primarily been designed to tackle sleep apnea, a condition that effects more than 1 billion people worldwide. Unfortunately statistics show that nearly 85% of those are unaware they have the condition and/or do not have access to clinical grade testing and appropriate therapy.
For those not in the know, this common and potentially serious disorder is characterized by interrupted breathing during sleep. Sufferers sometimes experience episodes hundreds of times per night. Stoppages in breathing may lead to the brain and the rest of the body not getting enough oxygen. You don’t want that.
The big news here is that the company has registered the wearable with the FDA as a Class II medical device. Its not at the approval stage just yet, but tests have shown that its margin of error is only 2.2% when compared to an arterial blood draw. This is well within the FDA allowed margin of error of 3.5% which means you can have confidence in its ability to measure oxygen saturation levels accurately.
The data securely sits in the Beddr Cloud until it is synced with the Beddr app via Bluetooth. The app provides personalized insights into your sleep quality and recommendations on how to improve it. The company says you may need a few nights of sleep to establish a baseline before more detailed statistics are churned out.
“Poor quality sleep can lead to a greater risk of a variety of chronic conditions, like type 2 diabetes, hypertension and depression” said Mike Kisch, CEO and co-founder of Beddr.
“The key to better sleep is breathing, and SleepTuner provides access to insights on oxygen levels that cannot be found in traditional consumer sleep trackers. We aim to empower anyone to figure out the cause of their poor sleep within a few days in the privacy of their own home.”
Sleep plays a vital role in good health and well-being throughout your life. Getting enough quality kip time at the right times can help protect your mental health, physical health, quality of life, and safety. SleepTuner is just one of a number of wearables designed to improve your nightly rest. But it may be the first one that comes with the FDA’s stamp of approval.
Those living in the US can order the $149 device now on the Beddr website. Shipping is expected to begin in November. International availability is yet to be announced.
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