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 […]
Product & Vendor Updates
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 […]
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 […]
QUVIVIQ Wins Best Biotechnology & Pharmaceutical Product
Idorsia Ltd announces that its novel treatment for insomnia disorder QUVIVIQ (Daridorexant) has been awarded the inaugural Prix Galien Bridges Award in the category of “Best Biotechnology & Pharmaceutical Product”. The award recognizes groundbreaking medicines, including biologics, gene therapies, and traditional pharmaceutical compounds, that advance patient care through scientific innovation. […]
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
DArway 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 […]
Panthera Announces Panthera DUO
Panthera Dental announced Panthera DUO, an ordering option that provides two appliances of the same design ordered together for the same patient. With choice of two different designs- Panthera Classic or Panthera X3– Panthera DUO helps dental practices maintain continuity of care and support adherence for patients who cannot afford […]
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 […]
The Sleep Wire
EnsoData Raises $20M to Accelerate Commercialization of AI-powered Sleep Solutions EnsoData, an innovator in AI healthtech solutions, announced a $20 million Series B financing led by Questa Capital. This new capital will enable EnsoData to accelerate adoption of its AI-powered sleep medicine solutions, improving the sleep care pathway for, in […]













