Aerocrine Inc, New Providence, NJ, announces that the NIOX MINO, a point-of-care
device for asthma patients, has received 510(k) clearance from the US Food and Drug
Administration (FDA).

NIOX MINO allows for the immediate measurement of fractional exhaled nitric
oxide (FENO), a method used for assessing airway inflammation that is
asthma-related. The NIOX MINO results can bring insights into treatment
efficacy for patients, as well as identify a patient’s non-compliance with

Over 22 million people in the United States are affected by asthma. The NIOX
MINO device can help asthma sufferers by monitoring the airway inflammation
itself, rather than just the symptoms.

“Historically, monitoring inflammatory airway diseases such as asthma
focused primarily on measuring symptoms and lung function,” says Trevor
Bourke, Aerocrine, Inc. “[Now] doctors can measure the underlying
inflammation that causes asthma within a few minutes directly in their

The NIOX MINO device is reimbursable through CPT code 95012, which applies
only to FDA approved devices.