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Tagged With "FDA"

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FDA Grants Clearance to Smart Inhaler Device to Help People With Asthma Improve Their Inhaler Technique

AAFA Community Services ·
BreatheSuite Inc., a Canadian connected respiratory health company, today announced that it has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) for its BreatheSuite Metered-Dose Inhaler (MDI) V1 device. Approved for both prescription and over-the-counter use, the BreatheSuite device turns existing MDIs into smart inhalers by automatically and objectively monitoring and providing feedback on inhaler adherence and technique for people with asthma and COPD.
Blog Post

What Is It Like to Live With and Manage Asthma in Childhood? Share Your Story With the FDA

AAFA Community Services ·
Update for Oct. 8, 2021: Did you miss the live stream of the PFDD meeting on childhood asthma? We are also still collecting stories about experiences living with and managing food allergy. See below for more information below on how to watch the recording and submit your comments . To bring the voice of patients and caregivers impacted by asthma in childhood to the forefront of drug development and research, the Allergy & Asthma Network, American Lung Association, American Partnership...
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Re: FDA Grants Clearance to Smart Inhaler Device to Help People With Asthma Improve Their Inhaler Technique

AllergyKid2006 ·
I too, am wondering if this will be a covered expense?
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Re: FDA Grants Clearance to Smart Inhaler Device to Help People With Asthma Improve Their Inhaler Technique

Compton ·
@Tia and @AllergyKid2006 -- we'll look into it to see what we can find.
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Re: FDA Grants Clearance to Smart Inhaler Device to Help People With Asthma Improve Their Inhaler Technique

Kathy P ·
@Tia74 and @AllergyKid2006 - it looks like these types of devices are not currently covered by insurance. At least one existing device has a program to provide them free for patients who qualify. So, I think it will be a wait and see to know how this one will be priced or if there will be a patient assistance program.
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