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Apr 04, 2019


FDA clears Spirosure's Fenom ProTM, point of care asthma device

Nagoya, April 4, 2019―NGK SPARK PLUG CO., LTD. (President, and COO:Takeshi Kawai, Headquarters: Nagoya, hereafter NGK SPARK PLUG) announces that the Fenom ProTM Nitric Oxide Test, manufactured by Spirosure has achieved FDA clearance for point-of-care use in hospitals and clinics.

Fenom Pro Nitric Oxide Test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. It is used by physicians, along with other tests, to diagnose and monitor allergic asthma. This condition affects approximately 20 million people in the United States, and about 3 million people in Japan. FeNO testing can help doctors and patients measure airway inflammation and take steps to reduce it, before asthma symptoms worsen.

Spirosure is a California-based company that was formed in 2011 to improve the lives of people with asthma by creating tools that enable doctors and patients to be proactive in their management of the disease.

NGK SPARK PLUG and Spirosure have been partners in this mission since 2014, and is a major investor in Spirosure.Spirosure is only the third manufacturer to ever gain FDA clearance for a FeNO monitor, and the first to do so in the past eight years.

Fenom Pro is currently sold in 11 countries, and is expected to launch in the US by the end of 2019 and in Japan by mid-2020.

* What is FDA?
The FDA is a government agency in the United States which specializes in administration such as foods, medicines and cosmetics, such as approval of products for consumers of everyday life.

■About Spirosure
Founded in 2011, the company's mission is to provide cost effective, non-invasive products for the management of chronic disease such as: asthma, COPD, and other chronic respiratory diseases for preventative healthcare through our proprietary sensor technology and algorithms.

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