Spirosure Makes FDA 510(k) Submission for Clearance to Sell Fenom PRO™ Point-of-Care Breathalyzer in the U.S.

Tuesday, Dec 12, 2017

Spirosure Inc. announced today it has made an FDA 510(k) submission seeking U.S. clearance for its Fenom PRO Point-of-Care Breathalyzer, launched in September at the world’s largest meeting for respiratory physicians, scientists and allied health professionals: the European Respiratory Society (ERS) International Congress 2017. Fenom PRO is CE-marked for use in Europe.

Spirosure's patent-protected, Fractional exhaled Nitric Oxide (FeNO)-based Fenom PRO™ breath analyzer is designed to help patients manage their asthma. This portable, non-invasive device uses state-of-the-art technology with proprietary algorithms to detect nanoscopic-sized NO molecules in concentrations of parts per billion (or “ppb”) in human breath. At point of care, the patient exhales at a slow rate for 10 seconds to generate results in less than 30 seconds. FeNO is increased in some airway inflammatory processes, such as asthma, and decreases in response to anti-inflammatory treatment. FeNO measurements with Fenom PRO may be used as part of regular assessment and for monitoring of patients with these conditions. Fenom PRO is suitable for children, approximately 5-17 years, and adults 18 years and older.

“Fenom PRO is a game-changing, connected medical device now being used by healthcare professionals in Europe as a tool that assists them in diagnosing and monitoring their patients’ asthma. It is comprised of sensors along with a digital ecosystem designed for supporting their clinical decisions,” said Dr. Solomon Ssenyange, Chairman and CEO of Spirosure.

Fenom PRO is designed to include use of a companion app and website, called Fenom CONNECT™. The Fenom CONNECT app will help patients follow their physician-developed asthma action plan and give them air quality and pollen information to help make informed decisions. The Fenom CONNECT website will allow physicians to quickly configure their patients’ asthma action plans and assess how their patients have been doing. Fenom CONNECT is designed to allow for even greater insight into patients’ issues, thus giving more information to the physician for improved clinical decision support.



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