Sleep Disorders

Narcolepsy Network Announces Addition of Two New Board Members
Central Disorders of Hypersomnolence Patient Advocacy

Narcolepsy Network Announces Addition of Two New Board Members

Narcolepsy Network, a national non-profit organization for people living with narcolepsy and idiopathic hypersomnia (IH), is proud to announce the appointment of Desireé Gorbea-Finalet and Mike Heil to its Board of Directors. Both new members live with narcolepsy and will bring fresh perspectives and deep advocacy experience to the organization as it prepares to […]

Alkermes Announces Phase 3 Brilliance Studies Evaluating Alixorexton for Narcolepsy Type 1 and Type 2
Narcolepsy Research/Studies Sleep Pharmaceuticals

Alkermes Announces Phase 3 Brilliance Studies Evaluating Alixorexton for Narcolepsy Type 1 and Type 2

Alkermes plc, announced the initiation of the Brilliance Studies, a phase 3 program evaluating the safety and efficacy of alixorexton compared to placebo in adults with narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). Alixorexton is the company’s novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development […]

LivaNova Receives U.S. FDA Premarket Approval for aura6000 System to treat Moderate to Severe Obstructive Sleep Apnea
Industry News Obstructive Sleep Apnea

LivaNova Receives U.S. FDA Premarket Approval for aura6000 System to Treat Moderate to Severe OSA

LivaNova PLC announced the U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) for the aura6000™ System for the treatment of adult patients with moderate to severe Obstructive Sleep Apnea (OSA). The System utilizes proximal hypoglossal nerve stimulation (p-HGNS), a differentiated neurostimulation modality, to treat OSA in patients with […]

Nexalin Announces Pivotal HALO Clarity Trial to Support Planned De Novo FDA Submission Targeting Multi-Billion-Dollar Insomnia Market
Industry News Insomnia Research/Studies

Nexalin’s HALO Clarity Trial to Support Planned De Novo FDA Submission Targeting Insomnia Market

Nexalin Technology, Inc. announced continued advancement toward its planned pivotal clinical trial evaluating HALO™ Clarity for the treatment of moderate to severe insomnia, designed to support Nexalin’s planned de novo submission to the U.S. Food and Drug Administration. The study is being conducted in collaboration with Lindus Health, a full-service clinical […]

remsleep holdings deltawave
CPAP/Interfaces

Full Commercial Launch of DeltaWave PAP Masks

REMSleep Holdings, Inc., developer of the FDA-cleared DeltaWave(TM) nasal pillow system, announced the full commercial launch of the DeltaWave product portfolio across all U.S. distribution channels, including durable medical equipment (DME) companies and institutional sales. With expanded FDA 510(k) clearance secured on January 15 and Medicare PDAC coding approved for every product […]