Other News

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 […]

Sleep to Overnight Clearing of Alzheimer's-Linked Proteins
Research/Studies

Study Links Sleep to Overnight Clearing of Alzheimer’s-Linked Proteins

What if sleep could help prevent Alzheimer’s disease? A new landmark study by researchers at Applied Cognition, a clinical-stage therapeutic company, points to the brain’s glymphatic system, its fluid-based “clean-up” pathway, as a key driver of overnight clearance of Alzheimer’s-linked proteins. The researchers found that during normal sleep, levels of amyloid beta and […]

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 […]

Clear Chronic Care Expands National Footprint as Medicare Infrastructure Partner for RPM, CCM and Quality Performance; Enters Sleep Medicine Market
Industry News

Clear Chronic Care Expands Nationally, Enters Sleep Medicine Market

Clear Chronic Care announced continued national expansion of its Medicare-focused Remote Patient Monitoring (RPM) and Chronic Care Management (CCM) platform, reinforcing its position as a long-term infrastructure partner to physician practices navigating value-based reimbursement. The company also announced strategic expansion into sleep medicine, where chronic oversight and adherence management are […]

ProSomnus Secures $38 Million Investment from Catalio Capital to Scale Smart Sleep Medicine
Industry News

ProSomnus Secures $38 Million Investment from Catalio Capital to Scale Smart Sleep Medicine

ProSomnus Sleep Technologies announced a strategic investment from Catalio Capital Management, L.P. to accelerate the global expansion of its technology-enabled sleep health platform. Under the agreement, Catalio, a premier healthcare-focused investment firm, has committed up to $38 million to advance development of next-generation remote patient monitoring (RPM) and proprietary sleep […]

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 […]