The Magazine for Sleep Professionals
Wednesday, March 25, 2026
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 […]
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 […]
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 […]
Inogen, Inc. has announced the launch of Aurora CPAP masks, a new product in its expanding portfolio. Aurora’s introduction marks a significant milestone in Inogen’s strategy to expand its respiratory care portfolio and now bring quality, high-performing masks to patients indicated for obstructive sleep apnea (OSA). Strategic Positioning and Market […]
Onera Health has announced the publication of a multicenter validation study of its Onera Sleep Test System (STS) in the Journal of Clinical Sleep Medicine, the official journal of the American Academy of Sleep Medicine. The study demonstrated that the patch-based Onera STS home-polysomnography (hPSG) performs comparably to gold-standard in-lab […]
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, […]
For the millions of people managing both obesity and obstructive sleep apnea (OSA), tirzepatide (Zepbound® and Mounjaro®, Eli Lilly and Co.) may offer a welcome approach to help reduce symptoms and improve overall health and quality of life. It’s been almost exactly a year since investigators of the SURMOUNT-OSA trial […]
There’s no one-size-fits-all approach for managing sleep apnea. Continuous positive airway pressure (CPAP) has been the go-to treatment for almost 40 years, but doctors have realized that some patients are not able to tolerate a CPAP mask or keep up with CPAP treatment over time. If you have a moderate […]
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 […]
