Inspire Medical Systems, Inc. Announces FDA Approval for Apnea Hypopnea Index Indication Expansion and Increased Body Mass Index Labeling

Medical technology company Inspire Medical Systems has received approval from the US Food and Drug Administration (FDA) for an expanded indication. The decision means that the upper limit of the Apnea Hypopnea Index (AHI) has been raised to 100 events per hour from 65, while the Body Mass Index (BMI) warning in labeling has been increased to 40 from 32. This approval allows Inspire's proprietary Inspire therapy to be used as a safe and effective treatment for moderate to severe obstructive sleep apnea patients who have historically had limited treatment options available. Data from its ADHERE registry demonstrated that it was a safe and effective treatment for this patient population. The company is focused on developing innovative, minimally invasive solutions for patients with obstructive sleep apnea. Keywords: Inspire Medical Systems, FDA, Apnea Hypopnea Index, Body Mass Index, obstructive sleep apnea Inspire Medical Systems' FDA approval marks a significant milestone for treating patients with obstructive sleep apnea who have not responded well to other treatments. With the expanded indication now approved by the FDA, these patients will have access to a safe and effective treatment option that was previously unavailable to them. The increase in AHI and BMI limits will allow more people to benefit