Healthcare Industry News: NIOX MINO
News Release - October 2, 2007
Aerocrine Submits 510(k) Filing for NIOX MINO(R) in the U.S.
SOLNA, Sweden--(HSMN NewsFeed)--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.
"We are now looking forward to co-operating with the FDA during its review process for NIOX MINO®," says Paul de Potocki, CEO of Aerocrine.
About Aerocrine
Aerocrine AB is a clinically based medical technology corporation dedicated to improved asthma management and care. Aerocrine was listed on the Stockholm Stock Exchange on 15 June, 2007. The company is marketing NIOX® Flex on a worldwide basis and is also marketing NIOX MINO®, representing a new generation of hand-held devices, in Europe. Both products are tailored for rapid, non-invasive control of the inflammatory status in the airways and may play a critical role for optimized asthma care and disease control. Aerocrine is located in Sweden with wholly owned subsidiaries in the US, UK and Germany.
Source: Aerocrine
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