Obstructive Sleep Apnea

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
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 […]

kricket cpap kpap sleepres
Sleep Disorders Central Sleep Apnea CPAP/Interfaces Obstructive Sleep Apnea PAP Therapy & Ventilation Systems Product/Vendor Updates

FDA Clears Kricket Positive Airway Pressure Device with KPAP

SleepRes, Inc. announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Kricket PAP device, powered by Kairos Positive Airway Pressure (KPAP)™ for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lbs. The SleepRes PAP system is intended for home, hospital/institutional, […]

Inspire Medical Systems, Inc. Publishes Inspire V Data at ISSS/AAO-HNS Meetings
Research/Studies Obstructive Sleep Apnea

Inspire Medical Systems, Inc. Publishes Inspire V Data at ISSS/AAO-HNS Meetings

Inspire Medical Systems, Inc. published Inspire V clinical outcomes data from its Singapore clinical study, as well as the Company’s limited market release in the United States, including single-site experience at two leading centers. These data will be presented at the American Otolaryngology-Head and Neck Surgery (AAO-HNS) and International Surgical […]

TAP Sleep Care Secures Full Medicare Portfolio Coverage: Nylon flexTAP® Receives PDAC Approval under E0486
Obstructive Sleep Apnea AASM Dental Sleep Medicine

Nylon flexTAP Becomes the First FDA-cleared 3D-Printed Midline Oral Appliance for Sleep Apnea

Airway Management proudly announces a historic milestone with the FDA clearance of Nylon flexTAP®, the world’s first digitally printed single-point midline oral appliance device for sleep apnea. This revolutionary device redefines patient care by combining cutting-edge patented Vertex Technology® with unparalleled comfort and efficacy, now FDA cleared for mild to moderate obstructive […]