Industry News

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 […]

Sunrise Announces Landmark SUNSAS Trial Results, an At-Home Sleep Apnea Diagnostic Pathway Compared with PSG
Clinical Insights Industry News

Sunrise Announces Landmark SUNSAS Trial Results, an At-Home Sleep Apnea Diagnostic Pathway Compared with PSG

Sunrise Group announced results from the SUNSAS clinical study, now published in The Lancet Regional Health – Europe, a leading international medical journal. Supported by the French Ministry of Health through the Forfait Innovation program, this study is the largest randomized controlled trial to date evaluating an at-home diagnostic pathway for obstructive […]

AAN Issues Guidance on the Use of Wearable Devices
Industry News Technology

AAN Issues Guidance on Wearable Devices

Wearable devices and digital apps that are available to consumers are emerging as potential tools in neurological care. These include smart watches and fitness trackers to monitor heart rate, physical activity, sleep and other health factors. To provide neurologists with guidance on the use, limitations and evidence on non-U.S. Food […]

Bleep LLC appoints Thomas P. Beckley to Board of Directors
Industry News

Bleep LLC appoints Thomas P. Beckley to Board of Directors

Bleep LLC, maker of the Eclipse™ mask-less CPAP solution, announced technologist and electronics industry veteran Tom Beckley has joined the Company’s Board of Directors. “As a successful technology entrepreneur with extensive knowledge of AI, software and advanced electro-mechanical systems, I’m very pleased Tom has joined Bleep’s Board of Directors,” said […]

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 […]