Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
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 [...]
On May 19, 2025, Apnimed announced positive topline results from its Phase 3 SynAIRgy clinical trial of AD109 (aroxybutynin 2.5 mg/atomoxetine 75 mg), an investigational once-daily oral pill for adults with mild, moderate and severe obstructive sleep apnea across all weight classes. About [...]
On April 4, the FDA granted De Novo clearance to the Prapela SVS hospital bassinet pad, a vibrating mattress pad designed to stimulate rhythmic breathing in premature newborns with neonatal opioid withdrawal syndrome (NOWS) through gentle, randomized movements. About Prapela SVS [...]
On March 20, Sibel Health announced its ANNE View and Central Hub received FDA 510(k) clearance to display data from ANNE devices and third-party monitors, providing alerts, patient positioning insights and multi-patient monitoring to support health care professionals. About ANNE View, [...]
Compumedics announced March 5 that its Falcon HST device received FDA 510(k) clearance, expanding the company’s home sleep testing lineup in the U.S. About Falcon HST Falcon HST is an electroencephalogram (EEG) and respiratory signal recorder. It records, reviews and analyzes [...]