The Magazine for Sleep Professionals
Wednesday, October 14, 2026
ProSomnus Sleep Technologies announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision […]
ProSomnus Sleep Technologies announced a strategic investment from Catalio Capital Management, L.P. to accelerate the global expansion of its technology-enabled sleep health platform. Under the agreement, Catalio, a premier healthcare-focused investment firm, has committed up to $38 million to advance development of next-generation remote patient monitoring (RPM) and proprietary sleep […]
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 […]
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 […]
For millions of people, the sound of teeth grinding is more than an annoyance—it’s a nightly neuromuscular storm. Sleep bruxism, characterized by involuntary clenching and grinding of the jaw during sleep, affects an estimated 8%–15% of adults worldwide.¹ Dentists have long turned to night guards as the standard solution, shielding […]
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 […]
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 […]
If your dentist or sleep physician has recommended oral appliance therapy to treat your obstructive sleep apnea (OSA), you might be wondering how it works. This guide walks you through the basics so you’ll know what to expect and how to get the best results. What Is a Mandibular Advancement […]
ProSomnus Sleep Technologies announced significant progress on strategic programs. The key feature is the successful FDA registration of the company’s HWO2 buccal mucosal wellness oximeter. The ProSomnus HWO2 Device enables patients to monitor their nightly health and wellness during sleep, specifically, blood oxygen saturation, pulse rate and overall use time, […]
Sleep apnea is a widespread sleep disorder affecting millions of Americans, yet many cases remain undiagnosed and untreated. Although the practice of screening patients with a home sleep test device by dentists is highly debated, as a board-certified sleep physician I firmly believe that dentists can play a crucial role […]
