The Magazine for Sleep Professionals
Thursday, February 5, 2026
DArway Management, the innovator behind TAP Sleep Care announced that its groundbreaking Nylon flexTAP® has received Pricing, Data Analysis, and Coding (PDAC) approval for HCPCS code E0486. This final approval means Airway Management is now the only oral appliance manufacturer in the United States with its entire portfolio of custom devices fully covered […]
ProSomnus Sleep Technologies (the “Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy®, 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 […]
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 […]
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 […]
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 […]
Onera Health announced that its wholly owned subsidiary in the Netherlands, Onera B.V., has received 510(k) market clearance from the U.S. Food & Drug Administration (FDA) for its ground-breaking system for Polysomnography (PSG) studies, Onera STS, paving the way for widespread deployment of the patch-based technology across healthcare systems in […]
Vapotherm, Inc. announced it has received 510(k) clearance from the US Food and Drug Administration for HVT 2.0. This next-generation system is designed to provide high-velocity therapy using an integrated air source, eliminating the need for wall air or any pressurized air source. It is estimated that 50% of U.S. […]
EnsoData Receives 510(k) Clearance of Latest Sleep Center Tools to Enhance Patient Care and Experience; Expands into Pediatrics and Unlocks Next Generation Home Testing Capabilities EnsoData, today announces its FDA 510(k) clearance of new capabilities and enhancements to its product EnsoSleep, a leading AI-assisted sleep scoring solution. With a substantial […]
