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 for an expanded indication that increases the upper limit of the Apnea Hypopnea Index (AHI) to 100 events per hour from 65, and raises the Body Mass Index warning in labeling to 40 from 32. The update will provide a safe and effective treatment option for patients with moderate to se..