July 11, 2023
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Inspire Medical Systems receives expanded indication for sleep apnea therapy
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The FDA has approved an expanded indication for a proprietary neurostimulation technology to treat those with severe obstructive sleep apnea.
According to a release from Inspire Medical Systems Inc, the regulatory body’s approval includes an increase on the upper limit of the therapeutic’s Apnea Hypopnea Index (AHI) to 100 events per hour from 65, as well as raising the BMI label warning to 40 from 32.
“We are excited that the FDA has approved Inspire’s application to expand our indication to include patients with AHI up to 100 events per hour,” Tim Herbert, president and CEO of Inspire, stated in the release. “These patients experience severe OSA and have historically had limited treatment options available.”