FDA Approves NIOX MINO for Asthma Monitoring

NIOX MINO®, a hand-held device for the measurement of airway inflammation and monitoring of patients with asthma, has just been 510(k) cleared by the FDA. NIOX MINO, a product of Swedish company Aerocrine AB, is designed to measure fractional exhaled nitric oxide (FENO), an inflammatory marker. The company promotes its product as a device that will “cost efficiently improve management and care of patients with inflammatory disorders, such as asthma.” The monitor is sensitive enough to detect as low as 5 particles per billion of exhaled nitric oxide.
 

More about the device, taken from the product page:

NIOX MINO Airway Inflammation Monitor is an easy-to-use handheld device that provides accurate, reproducible and immediate measurement of fractional exhaled nitric oxide (FENO). This is a proven and sensitive indicator of the inflammation that causes the symptoms of airway inflammatory diseases including asthma.

Current management of airway inflammatory diseases, including asthma, is achieved primarily by monitoring symptoms and lung function, with the treatment objective of bringing the disease under control. But the underlying cause of these respiratory symptoms and asthma attacks is airway inflammation, which until now could not be routinely measured.

NIOX MINO is 510(k) cleared (K072816) by the U.S. Food and Drug Administration (FDA) for clinical use and is the first hand-held tool to aid in asthma management by measuring airway inflammation. NIOX MINO is now approved for use in both adults and children. Measuring FENO using NIOX MINO is a reimbursable procedure.

NIOX MINO provides physicians in the U.S., for the first time ever, a powerful, easy-to-use tool that enables them to provide people living with inflammatory airway diseases, such as asthma, personalized inflammation control. By using NIOX MINO, doctors can provide the ideal level of therapy to each patient in order to achieve and maintain control of their symptoms.

NIOX MINO answers the need for a simple, accurate tool for assessing asthma control and responsiveness to treatment. NIOX MINO helps physicians achieve asthma treatment and management goals, allowing people with asthma to enjoy greater quality of life.

Product page: NIOX MINO…
Press release: FDA GRANTS MARKET CLEARANCE TO AEROCRINE INC.’S NIOX MINO®: A NEW HAND-HELD DEVICE TO MEASURE AIRWAY INFLAMMATION IN ASTHMA (.pdf)…