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US FDA Approves Handheld Device to Measure Airway Inflammation

Device: NIOX MINO®
Tradename: NA
Manufacturer: Aerocrine Inc.
Indication: Inflammatory marker to measure measure fractional exhaled nitric oxide

The US FDA has approved a handheld, point-of-care device for the measurement of airway inflammation and monitoring of patients with asthma.

NIOX MINO®, a product of Swedish company Aerocrine Inc., is designed to measure fractional exhaled nitric oxide (NO), an inflammatory marker. The monitor is sensitive enough to detect as few as five particles per billion of exhaled NO.

The company promotes its product as the first handheld device that provides "accurate, reproducible, and immediate measurement of fractional exhaled NO, a validated method for assessing asthma-related airway inflammation."

"NIOX MINO answers the need for a user friendly, noninvasive, accurate, and cost-effective tool that enables any physician to monitor the underlying process of asthma airway inflammation," said Peter Boggs, Clinical Professor of Pediatrics and Medicine, LSU School of Medicine, Shreveport. "What is important about this is that the control of airway inflammation is the key to the successful management of asthma, and this tool makes this possible."

Although the device would not replace spirometry, which measures pulmonary function, Aerocrine claimed that fractional exhaled NO measurement can capture inflammatory changes following allergen exposure at an earlier stage than spirometry, making it a more sensitive marker for asthma.



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