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I am a CE-certified medical device 
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General description
Additional info
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General description (provided by company)
Main purpose
Sunrise is a certified medical device for studying your sleep. It allows rapid and at home diagnosis of sleep apnea. The single-use sensor, sent directly to your home, connects to your phone in seconds. After the test, Sunrise also helps you to consult online with a certified sleep doctor or at the closest sleep center. The technology is clinically validated for adults and children.
Target audience
Sunrise is intended for adults and children with suspicions of sleep disorders. It is also intended to assist healthcare professionals in their diagnosis and prescription decision making.
Approach
In collaboration with sleep science experts, we’ve concluded that the chin is, in fact, the best spot to monitor your night from.
During sleep, it’s harder for the air to go through your respiratory tract because muscles have a tendency to relax/loosen (that’s one of the reasons why we snore). The respiratory tract is hence obstructed, leaving the organism deprived of oxygen. Luckily, the brain is informed of these disruptions and reacts by tightening the muscles of the upper airways to restore the air circulation.
These muscles are attached to a mobile bone, the mandible, which they move when they contract. By recording the movements of the mandible, it’s actually the small muscular adjustments ordered by the brain that we study in real-time. Placed on the chin, the sensor gives a faithful report of what the brain does to protect your breathing and your sleep.
Connected, light and comfortable, the Sunrise sensor relies on the latest innovations in terms of artificial intelligence. The app analyzes immediately from a secured cloud, the data gathered by the sensor. The purity of the signal received and the app using artificial intelligence account for Sunrise reliability. Clinical tests carried out on 400 patients show a 90% agreement with polysomnography for the diagnosis of obstructive sleep apnea. It’s the first time that such simple and user-friendly technology gets such good results!
During sleep, it’s harder for the air to go through your respiratory tract because muscles have a tendency to relax/loosen (that’s one of the reasons why we snore). The respiratory tract is hence obstructed, leaving the organism deprived of oxygen. Luckily, the brain is informed of these disruptions and reacts by tightening the muscles of the upper airways to restore the air circulation.
These muscles are attached to a mobile bone, the mandible, which they move when they contract. By recording the movements of the mandible, it’s actually the small muscular adjustments ordered by the brain that we study in real-time. Placed on the chin, the sensor gives a faithful report of what the brain does to protect your breathing and your sleep.
Connected, light and comfortable, the Sunrise sensor relies on the latest innovations in terms of artificial intelligence. The app analyzes immediately from a secured cloud, the data gathered by the sensor. The purity of the signal received and the app using artificial intelligence account for Sunrise reliability. Clinical tests carried out on 400 patients show a 90% agreement with polysomnography for the diagnosis of obstructive sleep apnea. It’s the first time that such simple and user-friendly technology gets such good results!
Connectivity to sensors and platforms
Sunrise is a medical device and consists of a mobile application, a sensor to be placed on the chin and a web platform for healthcare professionals.
Financing and pricing model
All information about our pricing model can be found on our website: https://hellosunrise.com.
Pathology
Sleep
Functions
Diagnostics
Treatment Support
Users
Everyone
Additional info
Compliance to M1 criteria
CE certification
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Granted by DQS Medizinprodukte GmbH
Assessed and certified meeting the requirements of:
Certificate granted on 09/03/2020
Certificate valid till 26/05/2024
Class type of medical device (More info): 2A
ISO Standards:
FAMHP registration and notification
Company registration number at FAMHP: 70145
Product identification code at FAMHP: 582423
General Data Protection Regulation (More info)
Reference publication
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2759126?widget=personalizedcontent&previousarticle=0
Pr Gozal D., n°1 global expert listed on expertscape.com;
Pr Pépin J-L., n°3 global expert listed on expertscape.com;
Dr Martinot J-B., Belgian sleep doctor.
Pr Gozal D., n°1 global expert listed on expertscape.com;
Pr Pépin J-L., n°3 global expert listed on expertscape.com;
Dr Martinot J-B., Belgian sleep doctor.
User instructions
The Sunrise sensor connects to your phone with Bluetooth. Once the Sunrise.sleep app is set up, you can scan the QR code on the envelope of your kit. All you need to do is start the analysis of your night on the app before falling asleep. A few minutes after you wake up, a detailed report allowing for a precise diagnosis of your sleep will be delivered.
Components of the application
Native appWeb applicationWearable / SensorMedical device
Complaints handling
Via e-mail: hello@hellosunrise.comVia telephone: +32 81 26 11 26
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