Clinical Insights

strategic alignment
ARTICLES Clinical Insights Patient Care

The New Hospital Sleep Ecosystem: 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 […]

Harmony Biosciences Receives U.S. FDA Approval for WAKIX (pitolisant) for the Treatment of Cataplexy in Pediatric Narcolepsy
Narcolepsy Sleep Pharmaceuticals

Harmony Biosciences Receives FDA Approval for WAKIX for the Treatment of Cataplexy in Pediatric Narcolepsy

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 cataplexy in pediatric patients 6 years of age and older with narcolepsy. WAKIX is now the first-and-only FDA-approved non-scheduled treatment for pediatric and adult […]

Alkermes Avadel Aquisition
Industry News Sleep Pharmaceuticals

Alkermes Completes Acquisition of Avadel, Accelerating Entry Into Sleep Medicine Market

Alkermes plc and Avadel Pharmaceuticals plc, announced Alkermes’ completion of its acquisition of Avadel, a commercial-stage biopharmaceutical company. The acquisition adds Avadel’s FDA-approved product, LUMRYZ®, to Alkermes’ commercial portfolio, and provides Alkermes with a commercial organization experienced in this disease state. This strategic move accelerates Alkermes’ entry into the sleep […]

New Study Shows Sunrise’s AI-Powered Measure of Respiratory Effort, REMOV, Better Reflects OSA Symptoms Than Traditional PSG Metrics
Obstructive Sleep Apnea Research/Studies Testing Modalities/Diagnostics

Sunrise’s AI-Powered Measure of Respiratory Effort, REMOV, Better Reflects OSA Symptoms Than Traditional PSG Metrics

Sunrise Group, a pioneer in medical device innovation and sleep care, today announced a new peer-reviewed study in Nature Communications Medicine. Sunrise developed the only home sleep test with respiratory effort measurement that has been validated against esophageal pressure, the reference standard. The study reveals that REMOV, the Sunrise-specific marker […]