SOLNA, Sweden--(BUSINESS WIRE)--Regulatory News: Aerocrine AB (OSTO:AERO) announced that it has submitted a 510(k) application for marketing clearance to the U.S. Food & Drug Administration (FDA) for its NIOX MINO® device. NIOX MINO® is the world’s first hand-held non-invasive device to measure the concentration of nitric oxide in exhaled human breath (FENO). Nitric oxide is a marker for airway inflammation originally discovered by Aerocrine’s founders. Today, FENO measurement is acknowledged in the scientific literature to have clinical relevance for the control of inflammatory airway disorders such as asthma. Evaluation of FENO measurements may constitute an important part of a disease management strategy to improve care of patients with inflammatory airway disorders.
