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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 ...
Also Read: FDA Labels Inspire Medical’s Sleep Apnea Nerve Stimulator Recall As Most Serious. The Inspire V system, expected to make a bigger impact in the second half of 2025 after the Inspire ...
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.
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]
Sleep apnea (sleep apnoea or sleep apnœa in British English) is a sleep-related breathing disorder in which repetitive pauses in breathing, periods of shallow breathing, or collapse of the upper airway during sleep results in poor ventilation and sleep disruption.
Obstructive sleep apnea (OSA) is the most common sleep-related breathing disorder and is characterized by recurrent episodes of complete or partial obstruction of the upper airway leading to reduced or absent breathing during sleep.
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The Food and Drug Administration (FDA) approved a weight-loss drug to help sleep apnea, becoming the first drug to treat the disorder affecting millions of Americans. On Friday, the federal agency ...