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 Aug. 12, 2021, Jazz Pharmaceuticals announced the FDA approved a new indication for Xywav for idiopathic hypersomnia (IH) in adults. About Xywav Xywav, also known as JZP258, is a lower-sodium oxybate treatment taken at night to help treat multiple symptoms of IH, [...]
On July 28, 2021, Takeda Pharmaceutical Company announced the FDA granted Breakthrough Therapy designation to TAK-994, which may provide a future treatment option targeting the orexin deficiency underlying narcolepsy type 1. About TAK-994 TAK-994 is a Phase 2 investigational oral orexin agonist designed to [...]
On July 14, 2021, EnsoData announced its FDA 510(k) clearance of new capabilities and enhancements to EnsoSleep, an artificial intelligence (AI)-assisted sleep scoring solution that automates event detection in polysomnography (PSG) and home sleep apnea tests (HSAT). About EnsoSleep EnsoSleep is software-only medical device [...]
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 [...]
On June 14, 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 [...]
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 [...]