Sleep Program Articles & Analysis
6 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. ...
(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 ...