Inspire Medical Systems Announces FDA Approval of Expanded Age Range for Inspire Therapy
Inspire Medical Systems, Inc. (INSP)
Last inspire medical systems, inc. earnings: 2/25 04:15 pm
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Source: GlobeNewswire
MINNEAPOLIS, April 21, 2020 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE: INSP) (“Inspire”), a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea (“OSA”), announced today that the U.S. Food and Drug Administration (“FDA”) has approved an expanded age range for Inspire therapy to include 18-21 year old patients, as compared to the previous minimum age requirement for patients to be 22 years old. Following a detailed review of the clinical evidence and iterative discussions with the FDA, Inspire believes that this is the initial step in the pediatric approval process, with further expansion to lower age groups possible. “This expanded approval represents meaningful progress in making Inspire therapy available to the pediatric population. The FDA and Inspire worked collaboratively to include the 18-21 year old population within the existing indication, and in th
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- 4/18/24 - Form 4
- 4/17/24 - Form 144
- 4/16/24 - Form 4
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