Nox Medical Virtual Product Launch Thursday, October 7th, 2021 8:00am PT / 11:00am ET / 17:00pm CEST In a time where we are seeing growth in awareness of sleep health and the demand for sleep studies continues to expand, polysomnography remains the gold standard for sleep studies. But not all […]
Product News
FDA Breakthrough Device Designation Granted to Genio System for OSA
Nyxoah SA has announced that the U.S. Food and Drug Administration has granted the Genio® bilateral hypoglossal nerve stimulation system Breakthrough Device Designation for the treatment of adult patients with moderate to severe OSA and Complete Concentric Collapse (CCC) of the soft palate. The FDA’s Breakthrough Designation Program was created […]
Sleep Technology Panelists Address Philips Recall
By Nathan Costiuc, MSN, APRN, FNP-BC There’s no denying that reliable respiratory equipment has become critical amid the COVID-19 pandemic. Yet new patient concerns have recently resulted from the June 14 Philips Respironics recall of several models of ventilators, BiPAP and CPAP machines due to a manufacturing defect. After navigating […]
NYU Accuses Resmed of Patent Breach Over Popular Sleep Apnea Product
According to NYU’s complaint filed in the Southern District of New York, the university sent Resmed chief executive Michael Farrell a letter in early June demanding the health group disable key features of its device within 24 hours. The company did not accede to NYU’s request. Resmed sells a range […]
Vapotherm HVT 2.0 Next Generation High-Velocity Therapy Gets FDA Approval
Vapotherm, Inc. announced it has received 510(k) clearance from the US Food and Drug Administration for HVT 2.0. This next-generation system is designed to provide high-velocity therapy using an integrated air source, eliminating the need for wall air or any pressurized air source. It is estimated that 50% of U.S. […]
New Product Bulletin: Baby Tape Plus Infant Endotracheal Tube Holder
click below to order B&B Baby Tape Plus™ is a pre-cut endotracheal tube holder made from a non-irritating, latex-free hydrocolloid adhesive that is skin-friendly for infants. Hydrocolloid tape safely secures and contours to the baby’s tender skin while the adhesive tape firmly attaches to the endotracheal tube. Baby Tape Plus™ […]
ResMed Launches AirSense 11 With New Tailored Features
ResMed today launched AirSense 11, available first in the U.S., the company’s next-generation PAP (positive airway pressure) device designed to help hundreds of millions of people worldwide with sleep apnea1 start and stay on therapy to treat and manage obstructive sleep apnea. AirSense 11 includes new features like Personal Therapy […]
New EnsoSleep FDA Clearance Includes Total Sleep Time for HSATs, Pediatric Scoring & Web-Based Platform
EnsoData announces its FDA 510(k) clearance of new capabilities and enhancements to its product EnsoSleep, a leading AI-assisted sleep scoring solution. With a substantial clinical study size, EnsoSleep’s validation metrics support diagnostic accuracy, helping sleep labs and healthcare systems provide care more efficiently and improve patient outcomes across the globe. […]
James A. Rowley, MD Named AASM Secretary/Treasurer
Dr. James A. Rowley became secretary/treasurer of the American Academy of Sleep Medicine board of directors during its annual membership meeting, which was live-streamed on June 14. The AASM is the leading professional society in the medical subspecialty of sleep medicine, with a combined membership of 11,000 individual members and […]
Ambu Supports FDA Recommendation of Single-use Bronchoscopes
The U.S. Food and Drug Administration has updated a safety communication on reprocessed flexible bronchoscopes. The FDA recommends that healthcare providers consider using single-use bronchoscopes where there is increased risk of spreading infection or no support for immediate reprocessing available. Additionally, the FDA recommends healthcare facilities consider using sterilization for reprocessing […]













