The FDA-registered consumer wearable SleepTuner, developed by the health technology startup Beddr, was presented today. It is intended to help you get more zz’s.
The fairly strange-looking, postage-sized gadget, which weighs only 5 grams, fastens to your forehead using a hypoallergenic disposable adhesive. The wearable then measures a wide range of metrics using optical sensors (with red infrared light) and a 3-axis accelerometer. This comprises heart rate, blood oxygen saturation (SpO2), sleep position, and breathing events that have halted.
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You might be asking at this point why it should be applied to your forehead. It is a strange way to approach the situation. According to the business, this is a clinically verified and reliable site for an optical sensor. It enables the continuous recording of sleep position and makes sure that blood oxygen and heart rate data readings are as accurate as possible.
The wearable main purpose is to treat sleep apnea, which affects more than 1 billion people globally. Unfortunately, data reveals that around 85% of people affected are either unaware they have the ailment or lack access to clinical grade testing and the necessary treatment.
For those who are unaware, this widespread and possibly dangerous disease is distinguished by sporadic breathing while sleeping. Episodes might occur hundreds of times for sufferers in a single night. The brain and the rest of the body may not receive adequate oxygen as a result of breathing pauses. It’s not what you want.
The wearable has been registered by the company with the FDA as a Class II medical device, which is big news in this case. Although it hasn’t reached the clearance stage yet, testing has revealed that it has a lower margin of error than an arterial blood draw—only 2.2%. You can trust that it will reliably monitor oxygen saturation levels because this is far under the FDA-allowed margin of error of 3.5 percent.
Beddr releases the first consumer sleep monitor with FDA registration.
Until it is Bluetooth synced with the Beddr app, the data is safely stored in the Beddr Cloud. The app offers suggestions on how to improve your sleep quality as well as personalised insights into your sleep patterns. Before more specific statistics are produced, the business advises that you may need to get a few nights of sleep to establish a baseline.
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According to Mike Kisch, CEO and co-founder of Beddr, “poor quality sleep can increase the risk of a range of chronic illnesses, such as type 2 diabetes, hypertension, and depression.”
Breathing is the secret to improved sleep, and SleepTuner gives users access to oxygen level information that is not available in conventional consumer sleep trackers. In only a few days, we want to provide everyone the tools they need to identify the source of their restless nights in the comfort of their own home.
Sleep is essential in order to maintain good health and wellbeing throughout your life. Your mental health, physical health, quality of life, and safety can all be preserved by getting enough, high-quality sleep at the appropriate times. One of many wearables created to enhance your overnight sleep is the SleepTuner. However, it might be the first to obtain the FDA’s seal of approval.
Americans may order the $149 gadget right away on the Beddr website. In November, shipping is anticipated to start. The availability in other countries hasn’t yet been disclosed.