Clinical Insights

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 Obstructive Sleep Apnea

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 […]

Robert Wood Johnson University Hospital Expands Sleep Testing Capacity by 290% After Implementing Wesper Dropship Model
Testing Modalities/Diagnostics

Robert Wood Johnson University Hospital Expands Sleep Testing Capacity by 290% After Implementing Wesper Dropship Model

Wesper announces Robert Wood Johnson University Hospital (RWJUH) Somerset has expanded monthly sleep testing capacity by 290% following the adoption of Wesper’s direct-to-patient, dropship home sleep testing model, according to a newly released whitepaper detailing the operational transformation. Prior to implementation, RWJUH Somerset faced growing demand for sleep apnea testing […]

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 […]

strategic alignment
ARTICLES Clinical Insights Patient Care

Why Are Hospitals Seeking Outsourced Partners, And Who Controls The Patient Pathway?

This rising demand collides with real operational constraints, such as credentialed technologists and physician shortages, aging equipment, getting out in front of evolving billing codes in 2026, and the modifications needed for the type of HST devices utilized, fragmented software, EMR integration requirements, capital constraints, and pressure to expand home‑based […]

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 […]

techno xperts julia sarmiento
Home Sleep Testing (HST) Polysomnography Product/Vendor Updates Testing Modalities/Diagnostics

Techno Xperts Builds Sleep Diagnostics Distribution Platform for Latin America

After more than two decades in the global sleep medicine industry, Julia Sarmiento, former Director of Sales of the Americas for SOMNOmedics US, has launched and rapidly expanded Techno Xperts, a dedicated distribution platform serving Latin America. The company was established to increase access to advanced sleep diagnostics technologies while […]