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The FDA has labeled a recall of Inspire Medical Systems, Inc.’s (NYSE:INSP) nerve-stimulating implant for obstructive sleep apnea as Class I, the most serious kind. Inspire initiated a recall of ...
Certain patients with obstructive sleep apnea who are deemed eligible candidates may be offered the hypoglossal nerve stimulator as an alternative. FDA-approved hypoglossal nerve neurostimulation is considered medically reasonable and necessary for the treatment of moderate to severe obstructive sleep apnea when all of the following criteria are met: [4]
Medicare may cover Inspire, a device to treat sleep apnea, if it is medically necessary. A doctor needs to demonstrate that people meet certain criteria and CPAP therapy has been ineffective.
Inspire is an implanted hypoglossal nerve stimulation device that treats obstructive sleep apnea by monitoring your breathing and delivering impulses to the nerve responsible for tongue movement ...
Sleep disorders including sleep apnea have become an important health issue in the United States. Twenty-two million Americans have been estimated to have sleep apnea, with 80% of moderate and severe OSA cases undiagnosed. [117] OSA can occur at any age, but it happens more frequently in men who are over 40 and overweight. [117]
This is a list of investigational sleep drugs, or drugs for the treatment of sleep disorders that are currently under development for clinical use but are not yet approved. Chemical/generic names are listed first, with developmental code names, synonyms, and brand names in parentheses.