Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies

FDA authorizes Philips PAP device repair program

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 [...]

2021-09-03T11:38:48-05:00September 2nd, 2021|Featured, Industry|

FDA issues safety communication for PAP recall by Philips

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 [...]

2021-07-23T12:14:24-05:00July 7th, 2021|Featured, Industry|

Philips issues Dreamstation CPAP recall notification

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 these [...]

2021-12-07T22:22:40-06:00June 14th, 2021|Featured, Industry|

FDA authorizes emergency use for PortPatch CPAP mask filter

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 [...]

2020-12-09T21:31:28-06:00December 9th, 2020|Industry|

FDA authorizes emergency use for Lumin on N95 respirators

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 [...]

2020-12-09T21:30:27-06:00December 4th, 2020|Industry|

FDA approves marketing of NightWare app to treat nightmares

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 [...]

2021-02-06T17:08:07-06:00November 6th, 2020|Industry|

FDA approves expanded use of Wakix for narcolepsy

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 [...]

2020-10-17T16:49:42-05:00October 17th, 2020|Industry|
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