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Sleep Program Articles & Analysis
9 news found
— September 29, 2021 — Sommetrics, a private company developing products and services to improve sleep health, today announced the launch of the pivotal clinical trial of its aerSleep® II device for the treatment of obstructive sleep apnea (OSA). ...
According to the FDA, OSA is an irreversibly debilitating human disease for patients with sleep apnea. Under the Program, the FDA will provide the Genio® system with priority review and interaction with FDA’s experts throughout the premarket review phase until the product is commercialized in the US. ...
The SUPRA clinical trial’s principal investigator, Dr. Kingman Strohl (Program Director in Sleep Medicine, University Hospitals Cleveland Medical Center, and Professor of Medicine, Case Western Reserve University, Cleveland OH) stated, “OSA is a major public health concern which detrimentally affects the quality of life for up to 20% of Americans. ...
(NYSE: INSP) (“Inspire”), a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea, today announced receipt of U.S. Food and Drug Administration (“FDA”) approval for an improved surgical implant procedure that eliminates one incision with a revised ...
The prevalence of sleep disorders, epilepsy and cardiovascular disease pose a significant challenge to the US healthcare system. Notably, 70 million Americans suffer from some form of a sleep disorder, 1 in 26 people will develop epilepsy or recurrent seizures during their lifetime, and 48% of all adults in the US have some type of cardiovascular disease. ...
— NOVEMBER 17, 2020 — Sommetrics, a private company developing products and services to improve sleep health, today announced its lead sleep apnea product, aerSleep II, has received FDA Breakthrough Device designation. ...
The funds will be used to further develop research and then seek FDA approval for a wearable sleep product to screen for sleep apnea. This would be a wireless, wearable, over the counter sleep apnea product. More than 18 million adult Americans have sleep apnea, according to the National Sleep Foundation. Up to ...
What makes these monitors unique are the advanced power management features which allow the instrument to be placed into remote environments, monitoring the air quality for more than a month on a single battery charge. The sleep mode function allows the instrument to sample air and then shut down all processes for a user-defined set time. After the programmed ...
The projects will help to restore the Sleeping Bear Dunes National Lakeshore and Grand Traverse Band watersheds and put people back to work, using a conservation corps model to hire unemployed workers to improve habitat and clean up shoreline. ...