The Magazine for Sleep Professionals
Friday, October 30, 2026
ProSomnus Sleep Technologies announces EVO Guided. EVO Guided is a new precision, custom oral device for the treatment of Obstructive Sleep Apnea (“OSA”). FDA cleared, patented and covered by most medical insurances, EVO Guided is the first oral device bioengineered to dilate the oropharynx and the velopharynx for optimal therapeutic […]
Axsome Therapeutics, Inc. a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has entered into a settlement agreement with Hetero Labs Ltd. and certain of its affiliates (Hetero) resolving patent litigation related to Axsome’s product SUNOSI® (solriamfetol). The litigation, which […]
EnsoData, a leader in healthcare AI technology, is partnering with Advanced Brain Monitoring (ABM) to add position data captured by ABM’s Night Shift sleep positioner into the FDA-cleared EnsoSleep PPG home sleep test (HST). Adding positional data to EnsoSleep PPG offers providers accurate supine AHI severity insights, leading to better […]
Panthera Dental is proud to announce that their abstracts were accepted for poster presentation at the AADSM and for poster and oral presentation at the SLEEP Annual Meetings. The oral presentation is part of a session entitled “Contemporary Management of Sleep Apnea” (O-13). Information regarding the 2025 IIR Grant will […]
Resmed announced its home sleep apnea test, NightOwl™, is now available across the United States. NightOwl is an FDA-cleared home sleep apnea test (HSAT) designed to offer healthcare providers a simplified, accurate, and efficient way to diagnose obstructive sleep apnea (OSA) from the comfort of an individual’s home. OSA, a […]
The thought of histamines might conjure up images of itchy hives or the tickling sensation just before a sneeze, but scientists have come to realize there is much more to histamines than their connection to allergies. Recent research reveals that histamines play a vital role in wakefulness. Produced by brain […]
The Slow Wave DS8™ oral appliance therapy (OAT), initially FDA-cleared for the prescription treatment of obstructive sleep apnea (OSA) in 2021 (K191320), has now been dually cleared by the FDA for the treatment of sleep bruxism (K240463). This makes the Slow Wave DS8, now marketed as BROSA™ when sold as […]
Harmony Biosciences announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for WAKIX® (pitolisant) tablets for the treatment of excessive daytime sleepiness (EDS) in pediatric patients six years of age and older with narcolepsy. The FDA separated the submission into two sNDAs […]
EnsoData, a pioneer in healthcare AI, achieved FDA 510(k) clearance for groundbreaking technology that enables AI-powered sleep diagnosis using FDA-cleared pulse oximetry (pulse ox) devices. Powered by EnsoSleep PPG scoring, widely available and wearable pulse ox technology can be deployed for a high-quality, accessible, and cost-effective approach to diagnosing sleep […]
Vivos Therapeutics, Inc. announced it has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) for treating severe obstructive sleep apnea (OSA) in adults using the Vivos’ removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances. Vivos’ CARE appliances include the flagship DNA oral appliance, the mRNA […]
