The Magazine for Sleep Professionals
Sunday, October 4, 2026
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death Recalled Product Airway Kit containing Sheridan® Endotracheal Tubes Model numbers: Kit TC7855 Distribution Dates: November 28, 2018 to June 5, 2019 Devices Recalled in […]
Resonea, Inc., a technology company founded to create a new standard for understanding sleep and breathing and their long-term impact on wellness, performance, and quality of life, announced that they obtained 510(k) clearance from the US Food and Drug Administration (FDA) on July 14, 2019 for their DROWZLE® Sleep Apnea Pre-screening Device. […]
Cook Medical and Zelegent, Inc., are now training physicians throughout the U.S. on the Elevo® Snoring Intervention Set after it received FDA 510(k) clearance in January. The set is used to treat snoring at a palatal level, and it expands treatment options for snoring. Elevo was officially introduced at the […]
The SOMNOtouch™ PSG is the smallest fully AASM compliant polysomnography device on the market today. In addition, our Home Sleep Camera is an innovative solution for synchronous video in an ambulatory setting – especially where reimbursement demands a video e.g. for pediatric or adult ambulatory polysomnography. A wireless camera can […]
Getting a good night’s sleep is hard to come by these days, especially when the daily stresses of life keep you up. In fact, a survey by Harris Poll on behalf of Vicks® ZzzQuil™ found that two-thirds of Americans say they have trouble falling asleep at least once a month. Additionally, only […]
Teleflex Incorporated has announced a worldwide recall of certain lots of Hudson RCI® Sheridan® Endotracheal Tubes. The recalled products are designed for oral or nasal intubation and are indicated for airway management. The products involved in this recall are as follows: The U.S. Food and Drug Administration (FDA) has classified […]
Murata Vios, Inc., a medical technology company that develops wireless patient-monitoring sensors and software, announced that it has received U.S. Food and Drug Administration (FDA) clearance for two 510(k) submissions for its second-generation wireless patient monitoring platform, the Vios Monitoring System (VMS). The approved suite of products provides a platform […]
Royal Philips has announced the company’s SmartSleep Deep Sleep Headband will be used in research funded by the Translational Research Institute for Space Health (TRISH), a virtual institute empowered by the NASA Human Research Program, for two unprecedented studies evaluating the relationship between sleep and cognitive performance for behavioral health. The two-year initiative […]
The AirAvant Medical team is looking forward to sharing their poster findings with the attendees at the SLEEP 2019 conference in San Antonio on June 8-12. The opportunity to engage with industry experts, doctors, and providers is sure to generate even more clinical interest in using the Bongo Rx, an […]
New system expands WatchPAT access to additional sleep centers by reducing infrastructure needs and eliminating capital requirements; also reduces infection risk for in-patient sleep apnea testing Itamar Medical Ltd. yesterday announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for WatchPAT One, the latest innovation […]
