ProSomnus, Inc. announced the presentation of four abstracts at the 2023 American Academy of Dental Sleep Medicine (AADSM) Annual Meeting, held May 19-21 in Philadelphia, Pennsylvania, and two abstracts at the American Thoracic Society (ATS) 2023 International Conference, held May 19-24 in Washington, D.C. The data presented at both meetings […]
Tag: HYPOGLOSSAL NERVE STIMULATION
Inspire Announces Expanded FDA Approval for Pediatric Patients with Down Syndrome
Inspire Medical Systems, Inc. announced today that it has received approval from the Food and Drug Administration (FDA) to offer Inspire therapy to pediatric patients with Down syndrome. “Since our first FDA approval in 2014, the research team at Mass Eye and Ear, led by Dr. Christopher Hartnick, have pioneered […]
Nyxoah OSA Implantable One Step Closer to Full FDA Approval
Nyxoah SA announced that the U.S. Food and Drug Administration (FDA) has approved the use of Nyxoah’s next-generation Genio® 2.1 system for use in the Company’s DREAM U.S. IDE pivotal study. Genio® 2.1’s upgrades are entirely related to the external components of the Genio® system, as the implantable stimulator remains […]
First Patient Implanted in OSPREY OSA Neurostimulator Clinical Study
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 Provides Update on 2022 Ambulatory Surgical Center Reimbursement Levels
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 […]
Sleep Tech First in World to Earn Unique Certification
Chief polysomnographic technologist David Moore recently became the first sleep disorders tech in the world to be fully certified in the Inspire Care Pathway, which is a set of best practices that guide use of the Inspire upper airway stimulation device that is implanted to treat sleep apnea. The UAB […]
FDA Breakthrough Device Designation Granted to Genio System for OSA
Nyxoah SA has announced that the U.S. Food and Drug Administration has granted the Genio® bilateral hypoglossal nerve stimulation system Breakthrough Device Designation for the treatment of adult patients with moderate to severe OSA and Complete Concentric Collapse (CCC) of the soft palate. The FDA’s Breakthrough Designation Program was created […]
Inspire Medical Systems, Inc. Announces FDA Approval of Two-Incision Implant Procedure
Two-incision approach reduces average procedure time by approximately 20 percent Inspire Medical Systems, Inc. has announced receipt of U.S. Food and Drug Administration (“FDA”) approval for an improved surgical implant procedure that eliminates one incision with a revised placement of the pressure sensing lead. This newly approved procedure will reduce […]
Inspire OSA Stimulation Therapy Now Covered By Cigna
Inspire Medical Systems, Inc. (“Inspire”) announced today that Cigna, one of the leading health plans in the United States, will provide coverage for the Company’s Inspire therapy (hypoglossal nerve neurostimulation), effective June 15, 2020. Cigna Corporation is a global health service company that provides health insurance coverage for approximately 16 […]
FDA Approves Expanded Age Range for Inspire Therapy
Inspire Medical Systems, Inc. announced today that the U.S. Food and Drug Administration (“FDA”) has approved an expanded age range for Inspire therapy to include 18-21-year-old patients, as compared to the previous minimum age requirement for patients to be 22 years old. Following a detailed review of the clinical evidence […]











