Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
On Feb. 5, 2021, the FDA authorized marketing of a new prescription device, eXciteOSA (formerly Snoozeal), to reduce snoring and mild obstructive sleep apnea. It is the first device used while awake that is intended to improve tongue muscle function, which in time can [...]
On Nov. 23 the U.S. Food and Drug Administration authorized the emergency use of the ventilator accessory PortPatch, which is intended to reduce the spread of airborne particulates through the exhalation ports, anti-asphyxia valves, and carbon dioxide vents on full-face or non-rebreathing CPAP masks [...]
On Dec. 3 the U.S. Food and Drug Administration authorized the emergency use of the Lumin LM3000 device for bioburden reduction of compatible N95 respirators that are contaminated or potentially contaminated with SARS-CoV-2 or other pathogenic microorganisms. The Lumin LM3000 utilizes ultraviolet germicidal irradiation [...]
On Nov. 6, 2020, the FDA permitted marketing of NightWare, an app that reduces sleep disturbances in adults 22 years of age or older who either have nightmare disorder or experience nightmares related to post-traumatic stress disorder. The FDA granted the marketing authorization to [...]
Harmony Biosciences announced on Oct. 13, 2020, that the U.S. Food and Drug Administration has approved Wakix (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. The FDA previously approved Wakix for the treatment of excessive daytime sleepiness in adult patients with [...]
Jazz Pharmaceuticals announced July 22, 2020, that the U.S. Food and Drug Administration has approved the Xywav oral solution for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy who are 7 years of age and older. Multiple Xywav dosing options [...]
Apple announced this week that its latest version of the Apple Watch operating system will include sleep tracking features. According to the Apple press release, watchOS 7 will track sleep timing and duration through “the detection of micro-movements from the watch’s accelerometer, which signals [...]
Inspire Medical Systems, Inc. announced April 21 that the FDA has approved an expanded age range for Inspire therapy for obstructive sleep apnea, lowering the minimum age from 22 years to 18 years. Inspire therapy is used for the treatment of moderate to severe [...]
The U.S. Food and Drug Administration has cleared the first prescription-based digital therapeutic for the treatment of chronic insomnia in adults, according to a press release from the product developer, Pear Therapeutics. Somryst, formerly SHUTi, uses cognitive behavioral therapy and data-based sleep restrictions to [...]
America’s largest company is trying to tackle one of the nation’s most complex issues — health care. In January, Walmart opened its second health center, offering primary and urgent care; dental, vision and hearing treatment; labs; X-rays; and other services. Walmart Health has the [...]