Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
On Sept. 1, Philips announced that it has received authorization from the Food and Drug Administration to “rework” the recalled first-generation DreamStation devices by replacing the sound abatement foam with a new material. Philips anticipates that the repair program will begin this month. The [...]
On June 30 the U.S. Food and Drug Administration (FDA) issued a safety communication in response to the voluntary recall by Philips of certain Philips Respironics bi-level positive airway pressure (BPAP), continuous positive airway pressure (CPAP), and mechanical ventilator devices due to potential health [...]
Today Philips issued a recall notification for specific Philips bi-level positive airway pressure (bi-level PAP), continuous positive airway pressure (CPAP), and mechanical ventilator devices. The recall is in response to potential health risks related to the sound abatement foam component in these devices. The [...]
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 [...]
