The Magazine for Sleep Professionals
Thursday, December 4, 2025
ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy®, today 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 […]
ProSomnus Sleep Technologies (the “Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy®, announces EVO Guided. EVO Guided is a new precision, custom oral device for the treatment of Obstructive Sleep Apnea (“OSA”). FDA cleared, patented and covered by most medical insurances, EVO Guided is the first oral device bioengineered […]
Sleep Specialists, LLC (DBA 2Z Medical) announces that Zzoma is now covered by a growing number of leading health insurance providers. This expanded coverage significantly increases access to this innovative, mask-free treatment option for individuals with positional OSA across the United States. Zzoma is an FDA-cleared positional therapy device indicated […]
Nyxoah SA today announced the appointment of Dr. Maurits S. Boon, MD as Chief Medical Officer. Dr. Boon joins Nyxoah from Thomas Jefferson University, where he will continue part-time as a professor and Vice Chairman, Education. He is dual board-certified in otolaryngology – head and neck surgery, as well as […]
Sleep Specialists, LLC, the manufacturer of Zzoma®, the FDA-cleared positional therapy device for mild to moderate obstructive sleep apnea (OSA), announced a significant milestone today. More than 1,000 sleep specialists across the United States are now prescribing Zzoma to their patients, and over 800 sleep clinics are actively offering it […]
Sleep Specialists, LLC, the manufacturer of Zzoma® positional therapy for obstructive sleep apnea (OSA), and iSleep Physicians, a leading virtual sleep specialist practice, have announced a collaboration to improve access to effective OSA treatment options for patients nationwide, offering a comfortable and potentially mask-free alternative to traditional CPAP therapy. Zzoma […]
A machine commonly used for pain relief has shown to improve breathing in patients with obstructive sleep apnea, a clinical trial has found. Results of the TESLA trial, published today in eClinical Medicine by researchers from King’s College London and Guy’s & St Thomas’ NHS Foundation Trust, shows the potential of a […]
LivaNova PLC has announced the first patient implanted in the investigational device exemption (IDE) clinical study, “Treating Obstructive Sleep Apnea using Targeted Hypoglossal Neurostimulation” (OSPREY). The randomized controlled trial (RCT) seeks to demonstrate the safety and effectiveness of the LivaNova aura6000™ System, an implantable hypoglossal neurostimulator intended to treat adult patients with […]
Inspire Medical Systems, Inc. is providing an update on the 2022 Reimbursement payment rates for Inspire procedures performed in Ambulatory Surgical Centers (ASCs). The Centers for Medicare and Medicaid Services (CMS) today published updated addendum files for the 2022 ASC payment system, including updating the assigned device offset percentage and […]
Sommetrics, a private company developing products and services to improve sleep health, has announced its lead sleep apnea product, aerSleep II, has received FDA Breakthrough Device designation. This program allows for additional FDA feedback to sponsors during the pre-marketing phase but does not alter the basic requirements for market authorization. […]
