The Magazine for Sleep Professionals
Sunday, September 20, 2026
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 […]
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 […]
Getinge announces clearance from the FDA of several new software options for the Servo-u and Servo-n ventilators. In addition to the latest software upgrades, Getinge also received clearance for the new Servo-u MR ventilator for the MRI room. “The COVID-19 pandemic and the heightened awareness of respiratory health have driven […]
Medical design firm, Nectar Product Development, and its affiliated medical device company, BreathDirectTM, announced that its BDR-19TM ventilator has received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA). Approval of the BDR-19TM for the critical care of patients with ventilatory insufficiency comes after an extended review process by FDA regulators […]
Vivos Therapeutics, Inc., a medical technology company focused on developing and commercializing innovative treatments for patients suffering from sleep-disordered breathing, including obstructive sleep apnea (OSA), announced the launch of VivoScore, powered by SleepImage®. VivoScore is a comprehensive home sleep apnea test (“HSAT”) that utilizes proprietary cardiopulmonary coupling technology developed by […]
Rhythmlink International, LLC has announced FDA clearance of a new product line. Sticky Pad™ Surface Electrodes, a line of peel and stick-on electrodes for Intraoperative Neurophysiological Monitoring (IONM) and Electroencephalography (EEG) are now FDA Cleared MR Conditional for 1.5 and 3 Tesla MRI environments. Rhythmlink has been selling a line […]
Breas Medical USA has announced the market introduction of the Vivo 45 LS, one of the smallest, full-featured life support devices on the market. The Vivo 45 LS is cleared by the FDA to provide both invasive and non-invasive continuous or intermittent ventilatory support across the continuum of care in […]
The U.S. Food and Drug Administration (FDA) is informing health care providers and health care facilities about up-to-date information concerning multiplexing ventilator tubing connectors, also known as ventilator splitters, in situations in which no alternatives for invasive ventilatory support are available. Although the FDA has not received any adverse event […]
3B Medical, Inc. has received FDA 510(k) clearance on its new third-generation bi-level device, the Luna G3 Auto-BPAP. The Luna G3 Auto BPAP is a modern and technologically advanced Bi-Level PAP therapy device for the treatment of obstructive sleep apnea. This device is available with integrated heated tubing, cellular connectivity […]
ClearMask™ is the world’s first FDA-cleared, fully transparent surgical mask suitable for hospitals, clinics, schools, retail, hospitality, and other settings. The mask is optimized for maximum clarity and comfort and meets applicable ASTM Level 3 requirements for fluid resistance and flammability, which offers a high level of protection for medical […]
