Resonea, a technology company focused on sleep and breathing, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its DROWZLE sleep apnea pre-screening device.
Image: The FDA-cleared DROWZLE device is established as a distinct brand. Photo: Courtesy of The U.S. Food and Drug Administration/Wikipedia.
Resonea is engaged in creating a new standard for understanding sleep and breathing and their long-term impact on wellness, performance, and quality of life.
DROWZLE is a Class II prescription medical device and works on smartphone-based software that records and analyses respiratory pattern during sleep to facilitate the in-home screening of obstructive sleep apnea (OSA).
Following commercialisation, the FDA-cleared DROWZLE device is planned to be established as a distinct brand to distinguish it from the current consumer-oriented DROWZLE Sleep Health platform.
Resonea CEO and co-founder Ruchir Sehra said: “Sleep breathing disorders are common, costly, dangerous and often worsen other health conditions, such as diabetes, heart disease, obesity and depression. While consumer awareness about sleep apnea has increased, most patients with OSA still do not know they have the disease.
“Our society has not made adequate progress helping people to understand their risk for OSA or motivating those at risk to seek appropriate care. The clearance of the DROWZLE technology makes in-home screening of adults with possible sleep breathing disorders much easier.”
The company said that its DROWZLE software collects symptom data for sleep apnea risk, including the severity of daytime sleepiness and personal chronic disease risk factors.
In addition, DROWZLE records sleep breathing patterns and send the sound files to the cloud-based secure servers with advanced algorithms to analyse the results.
The device enables healthcare providers to measure and monitor sleep disorder health risks over time and provide the generated HIPAA-compliant reports to the individuals through the mobile application and secure, encrypted email.
Resonea co-founder and chief medical officer Karen Underwood said: “What’s unique about DROWZLE is that it can perform in-home screening without any sensors attached to the body. The ease of use and convenience can reduce key obstacles to getting tested.
“DROWZLE also delivers educational and motivational content to help spur those who are at risk to see their provider for recommended treatment and follow up. Increased accessibility to screening can result in more people receiving medical care.”