The Food and Drug Administration has granted 510(k) clearance to CapMedic®, an interactive digital inhaler sensor for use with traditional metered dose inhalers (MDI) for the treatment of asthma, chronic obstructive pulmonary disease and other pulmonary conditions.

CapMedic® is a class II medical device that uses audio-visual cues to guide individuals through the process of correctly using their inhaler. This includes a reminder to shake the inhaler before use, LED lights that alert the patient to correct inhaler orientation, lights, sounds and vibrations to remind the patient to actuate the inhaler, music and lights during inhalation, and a reminder to the patient to hold their breath at the end of inhalation. 

The device also contains a built-in spirometer, which tracks the users progress by measuring forced expiratory volume in 1 second (FEV1) and peak expiratory flow. The data can be transferred to a dedicated smartphone app, which allows for remote patient monitoring by healthcare providers. 

“CapMedic brings us the data we didn’t have before,” said Dr Chris Landon, a pediatric pulmonologist piloting the device at the Pediatric Diagnostic Center in Ventura, CA. “We have seen our little patients, and our big ones, loving the sounds and lights of CapMedic while improving their technique. Parents synchronize lung function and medication data with their smartphone app which gives us a snapshot of their compliance remotely.”


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The device can be attached to Ventolin®, Proair®, Symbicort®, Advair®, Flovent®, Dulera®, Proventil® Asmanex®, Xopenex®, Alvesco®, and Atrovent®.

Currently, the CapMedic inhaler guidance tool and home spirometer for patient use is available online for $99.

For more information visit capmedicinhaler.com.