Sleep Disorders

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

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
Industry News Product News Sleep Apnea

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 […]

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

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 […]

In November, the Percentage of Patients with a Telehealth Claim Increased Nationally and in Every Region
Digital Health Industry News Sleep Disorders Technology

In November, the Percentage of Patients with a Telehealth Claim Increased Nationally and Regionally

The percentage of patients with a telehealth claim increased nationally and in every region in November 2025, according to FAIR Health’s Monthly Telehealth Regional Tracker. Nationally, that percentage increased from 14.5 percent in October to 15.0 percent in November, a 3.6 percent rise. The largest increase was in the Midwest, at 5.1 […]

Sunrise Announces Landmark SUNSAS Trial Results, an At-Home Sleep Apnea Diagnostic Pathway Compared with PSG
Artificial Intelligence Research & Studies Sleep Apnea Technology

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 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 of […]

Louisiana Startup SleepNavigator® Secures Statewide Investment to Scale Sleep Care Technology Nationally
Industry News Sleep Apnea Sleep Disorders Technology

Louisiana Startup SleepNavigator Secures Statewide Investment to Scale Nationally

SleepNavigator Inc., a Louisiana-built medical software company addressing widespread breakdowns in U.S. sleep medicine, has raised its first round of funding from a coalition of statewide investors including Ochsner Health, Boot 64 Ventures, and New Louisiana Angel Fund 3. The investment positions the homegrown company to expand nationally at a […]