The Magazine for Sleep Professionals
Friday, October 30, 2026
ProSomnus Sleep Technologies announced the formation of its inaugural Medical Advisory Board, significant enhancements to its RPMO₂ platform, and growing clinical evidence supporting precision oral appliance therapy (OAT), including results from the FLOSAT study. These advancements will be highlighted during the company’s participation at CHEST 2026, October 19-21, 2026, in […]
Mosanna Therapeutics, Inc., announced results from its Phase 1 MOSAIC study. MOS118 was safe and well tolerated across all doses, with no serious adverse events reported. These results support progression of the study into patients with OSA. “With these results we can now proceed to evaluate MOS118 in the patients it […]
HoneyNaps, an AI-based sleep medicine company, announced that SOMNUM V3.0, its AI diagnosis software for polysomnography (PSG) analysis, has received U.S. Food and Drug Administration (FDA) clearance under clearance number K253390. SOMNUM is clinical decision support software designed to assist medical professionals in analyzing PSG data, including sleep staging and […]
Huxley Medical, a commercial-stage medical technology company expanding access to sleep apnea testing across health systems, cardiology, and primary care, introduced two additions to its SANSA® platform: SANSA GO™, a point-of-care enrollment model that enables clinics to dispense SANSA at patient visits, and hypoxic burden, an additional measure of cardiovascular […]
ResMed announced that it has entered into a definitive agreement to acquire Noctrix Health, a medical technology company focused on treating restless legs syndrome (RLS). The acquisition marks a strategic expansion of ResMed’s portfolio into adjacent neurological sleep disorders, reinforcing its mission to improve patient outcomes and quality of life. […]
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 […]
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 […]
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, […]
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 […]
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 […]
