Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
On Sept. 4, 2025, Compumedics announced that it received FDA 510(k) clearance for Somfit-D, a single-use, home-based sleep monitoring device that records signals from a patient’s forehead. About Somfit-D Somfit-D is a noninvasive, single-use prescription device designed for home use in [...]
On August 14, 2025, Nox Medical announced the U.S. launch of the Nox SAS solution, an advanced EEG technology that enables polysomnography (PSG) testing in any setting. About Nox SAS Nox SAS, short for self-applied somnography, is a simplified EEG montage developed for [...]
On Aug. 8, 2025, Nyxoah announced that the FDA approved the Genio system for a subset of patients with moderate to severe obstructive sleep apnea (OSA) who have an apnea-hypopnea index (AHI) between 15 and 65. About Genio Genio is a hypoglossal nerve [...]
On July 23, Apnimed announced positive topline results from LunAIRo, the second phase 3 clinical trial of AD109 (aroxybutynin 2.5mg, atomoxetine 75mg) in adults with obstructive sleep apnea. Apnimed previously announced results from its SynAIRgy trial of AD109 in May. LunAIRo study results [...]
In July 2024, REMSleep Holdings received FDA 510(k) clearance for its DeltaWave Nasal Pillow System, a CPAP interface mask designed to improve comfort and airflow for patients undergoing positive airway pressure therapy. About REMSleep’s DeltaWave mask The DeltaWave Nasal Pillow System is a [...]
Centessa Pharmaceuticals announced that the U.S. FDA has cleared its investigational new drug (IND) application for ORX142, a novel orexin receptor 2 agonist in development for sleep-wake disorders and select neurological and neurodegenerative conditions. About ORX142 ORX142 is an investigational, novel, highly potent [...]
ProSomnus has expanded its EVO line with a new oral appliance designed for obstructive sleep apnea. Called EVO Guided, the company says it is the first bioengineered oral device intentionally designed to dilate both the velopharynx and the oropharynx. About EVO Guided ProSomnus EVO [...]
DormoTech introduced DormoVision X, a wireless, AI-powered home sleep testing platform, during the SLEEP 2025 annual meeting in Seattle. The system is being marketed under a new name but is based on the DormoTech Nlab device, which received FDA clearance in December 2024.About DormoVision [...]
The Viatom Smart Ring Pulse Oximeter – O2Ring received FDA approval in February 2025. This wearable device measures pulse rate and blood oxygen saturation (SpO2) levels, and is designed for use in both clinical and home settings. About the O2Ring The Viatom Smart [...]
On June 5, 2025, Avadel Pharmaceuticals announced that the FDA granted orphan drug designation to Lumryz, its extended-release sodium oxybate medication, for the treatment of idiopathic hypersomnia (IH). The FDA’s orphan drug designation provides incentives for drugs and biologics for the treatment of rare [...]