Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
On November 6, 2025, AIOMEGA announced it has received FDA 510(k) clearance for its oral appliance, AIO Breathe, in children and adolescents with mild to moderate obstructive sleep apnea (OSA). About AIO Breathe The AIO Breathe is a custom oral appliance designed to [...]
On Oct. 27, 2025, Good Sleep Co announced that the Hushd Pro Z-Link has received FDA 510(k) clearance. It is a precision-engineered mandibular advancement device intended to reduce or alleviate snoring and mild-to-moderate obstructive sleep apnea in adults. About the Hushd Pro Z-Link [...]
By Pahnwat Tonya Taweesedt, MD Unlike sleeping at home or in a hotel during a vacation, sleeping with polysomnography (PSG) equipment in a sleep lab might not be a pleasant experience for patients. Even though in-lab PSG is the gold standard for diagnosis [...]
By Michael S.B. Mak, MD, FAASM, and Stanley K.L. Wong, MD We see that public interest in sleep health is consistently growing — no doubt supported by the AASM’s healthy sleep campaigns and advocacy from our membership. More than one-third of Americans have [...]
On Sept. 9, Apple introduced the Apple Watch Series 11, which includes new tools to help users track and improve sleep quality. Sleep score tracks quality and patterns The Apple Watch Series 11 collects sleep data such as heart rate, wrist [...]
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 [...]