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

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 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|

FDA approves Xywav to treat narcolepsy

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 [...]

2020-10-21T11:09:35-05:00July 23rd, 2020|Industry|

New Apple Watch operating system includes sleep tracking

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 [...]

2020-06-26T17:19:39-05:00June 26th, 2020|Industry|

Digital treatment for insomnia receives FDA clearance

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 [...]

2020-03-26T22:32:34-05:00March 26th, 2020|Industry|

Walmart takes on health care delivery

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 [...]

2020-03-06T01:09:59-06:00March 6th, 2020|Industry|

Oral device to treat sleep apnea cleared by FDA

Australian-based Oventus has received clearance from the U.S. Food and Drug Administration for an oral device to treat obstructive sleep apnea, according to a Sept. 2, 2019, company statement. The O2Vent Optima is a customized, 3D-printed, nylon oral device that stabilizes the patient’s upper [...]

2020-02-26T18:25:01-06:00March 5th, 2020|Industry|

Walgreens attempts to connect customers to sleep solutions

Hoping to improve the nation’s sleep and expand its services to consumers, Walgreens has added sleep disorders to the growing list of chronic conditions it can help treat. The pharmacy’s digital platform, Find Care, connects consumers to health services like virtual doctor visits, online [...]

2020-02-26T18:05:51-06:00March 2nd, 2020|Industry|