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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 ...
The settlement stems from a lawsuit filed following a 2020 walkout during contract negotiations. Fresno healthcare system, doctor group settle over ‘unprecedented neurosurgeon walkout’ Skip to ...
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]
The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
The following is a list of the 21 largest civil settlements, reached between the United States Department of Justice and pharmaceutical companies from 2001 to 2017, ordered by the size of the total civil settlement. Some of these matters also resolved criminal fines and penalties, listed in parentheses, but these amounts are not considered when ...
The out-of-pocket cost for the Inspire sleep apnea implant may be: $1,796 at a hospital outpatient surgical center. $5,133 at a non-hospital surgical center.
A little over 50% of all people with Down syndrome experience obstructive sleep apnea, [59] and some physicians advocate routine testing of this group. [60] In other craniofacial syndromes, the abnormal feature may actually improve the airway, but its correction may put the person at risk for obstructive sleep apnea after surgery when it is ...