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..

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  • · 2023. 6. 11.
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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..

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  • · 2023. 6. 10.
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