Le Lézard
Classified in: Health
Subject: FDA

RESONEA Obtains FDA Clearance for Smartphone-Based In-Home Screening for Obstructive Sleep Apnea

SCOTTSDALE, Ariz., July 25, 2019 /PRNewswire/ -- Resonea, Inc., ("Resonea" or the "Company") a technology company founded to create a new standard for understanding sleep and breathing and their long-term impact on wellness, performance, and quality of life, announced that they obtained 510(k) clearance from the US Food and Drug Administration (FDA) on July 14, 2019 for their DROWZLE® Sleep Apnea Pre-screening Device. 

DROWZLE is a prescription, Class II medical device that consists of stand-alone smartphone-based software (operating on Apple iPhone 7, 8, or X model using iOS v10.0 or later) that records and analyzes respiratory patterns during sleep for the purpose of in-home screening for obstructive sleep apnea (OSA).  Results are used to assist healthcare professionals in determining the need for additional diagnosis and evaluation.  Upon commercialization, the FDA-cleared DROWZLE device will be distinctly branded to differentiate it from the current consumer-oriented DROWZLE Sleep Health platform. 

DROWZLE software collects symptom data for sleep apnea risk, including severity of daytime sleepiness and personal chronic disease risk factors.  DROWZLE also records sleep breathing patterns and sends the sound files to secure servers in the cloud for proprietary algorithms to analyze the results.  Along with the profile data, this helps providers measure and monitor sleep disorder health risks over time. HIPAA-compliant reports are generated and provided to the individual and their healthcare provider via the mobile application and secure, encrypted email.

"Sleep breathing disorders are common, costly, dangerous and often worsen other health conditions, such as diabetes, heart disease, obesity and depression," acknowledged Ruchir Sehra, MD, CEO and co-founder of Resonea.  "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."

Karen Underwood, MD, Chief Medical Officer and co-founder of the Company, 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."

In an IRB-approved study of 242 individuals undergoing clinically indicated polysomnography (PSG) in sleep labs, with sleep breathing data simultaneously collected through smartphones, the DROWZLE algorithm was tested against the PSG results, providing a sensitivity of 93.7% to detect people with moderate and severe OSA. The inclusion of validated sleep apnea risk questionnaires reinforces the effectiveness by further reducing the potential for false negative results.

Media Contact:  media@resonea.com

About Resonea Inc.

RESONEA is creating a new standard for understanding sleep and breathing and their long-term impact on wellness, performance, and quality of life.  The DROWZLEtm Sleep Health Program helps to detect people at risk for costly, dangerous and often hidden sleep disorders using cloud-based analytical software delivered through smartphones. DROWZLE can help people discover their sleep breathing health, educate them to change their sleep habits, and motivate them to seek help when needed. DROWZLE also provides long-term follow-up to demonstrate how improving sleep health benefits their quality of life and ability to function.  

For more information on Resonea Inc., go to www.resonea.com


SOURCE Resonea

These press releases may also interest you

at 09:20
Merakris Therapeutics, LLC., a leader in innovative approaches for cutaneous wound healing, announces that the Centers for Medicare & Medicaid Services (CMS) has assigned a Healthcare Common Procedure Coding System (HCPCS) product code Q4248 for its...

at 09:15
Pfizer Inc. announced today it has pledged $100 million to the new Antimicrobial Resistance (AMR) Action Fund, which launched today, to help address the significant global public health need for new antibiotics due to the rapid rise of...

at 09:15
Zynex, Inc. , an innovative medical technology company specializing in manufacturing and selling non-invasive medical devices for pain management, stroke rehabilitation, cardiac monitoring and neurological diagnostics, today announced orders and an...

at 09:13
In an effort to recognize the importance of providing PPE to those in need and to kick off the sale of a new line of PPE kits to businesses and consumers, CLEANLIFE® LLC has made a donation of kits and supplies to local shelters and non-profits...

at 09:12
Mundipharma today announced that laboratory testing at the Duke-NUS Medical School in Singapore, has confirmed the effectiveness of its BETADINE® antiseptic products against the novel coronavirus (SARS-CoV-2) which causes COVID-19 disease....

at 09:08
Vital Data Technology, a data science-driven healthcare technology solutions provider has launched Affinit? Risktm, a comprehensive, purpose-built application that allows health plans to efficiently and accurately perform risk adjustment processes...

News published on 25 july 2019 at 10:22 and distributed by: