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 […]
Product News
Resmed Introduces Full Face Fabric Mask Designed for Comfort and Improved Sleep Health
Resmed, announced the launch of the AirTouch™ F30i Comfort mask in the United States, a new CPAP (continuous positive airway pressure) full face mask. With a soft, breathable1 fabric, the AirTouch F30i Comfort is designed to help more people start and stay on CPAP therapy. The AirTouch F30i Comfort reflects Resmed’s dedication […]
AesyBite Oral Appliance Uses Biofeedback to Reduce Bruxism by 60%
Aesyra SA has announced the successful completion of its clinical investigation evaluating the efficacy and safety of AesyBite™ Active, an intelligent oral appliance designed to treat and prevent sleep bruxism through biofeedback. The clinical investigation demonstrated that AesyBite™ Active achieved a statistically significant and clinically meaningful reduction in sleep bruxism activity, exceeding the […]
Inogen Launches Aurora CPAP Masks
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 […]
Patch-Based Onera Sleep Test Demonstrates PSG Accuracy Outside the Sleep Lab
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 […]
Fisher & Paykel Healthcare launches Nova Nasal Mask in the U.S.
Fisher & Paykel Healthcare has announced the United States launch of its newest nasal PAP mask for treating obstructive sleep apnea, the F&P Nova Nasal mask. Building on the success of the F&P Nova Micro™ and F&P Solo™ masks, the new F&P Nova Nasal delivers advanced technology to enhance mask […]
Daybreak Offers At-Home Dentist-Guided Model for Oral Appliances
A new Cedars Sinai Physician Associated Study is among the largest real-world evaluations of mandibular advancement device therapy for mild to moderate obstructive sleep apnea (OSA) and one of the first to examine a fully virtual, dentist-led care model from diagnosis through treatment and follow-up. Using the processes and care […]
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, […]
TAP Sleep Care Secures Full Medicare Portfolio Coverage: Nylon flexTAP Receives PDAC Approval under E0486
Airway Management, the innovator behind TAP Sleep Care announced that its groundbreaking Nylon flexTAP® has received Pricing, Data Analysis, and Coding (PDAC) approval for HCPCS code E0486. This final approval means Airway Management is now the only oral appliance manufacturer in the United States with its entire portfolio of custom devices fully covered […]
Belun Introduces New Features & Innovations in Sleep Monitoring
Belun is excited to share some important updates to the Belun Sleep Platform, designed to bring more insights and improved interface for clinicians and researchers in sleep medicine. The latest update introduces trend-plotting capability for patient data, allowing you to: Track longitudinal changes in sleep and physiological data; Visualize patient treatment progress over time; Support clinical decision-making […]













