Spirosure’s Fenom PRO™ Point-of-Care Breathalyzer 510(k) Submission

Spirosure Inc. has made a U.S. FDA 510(k) submission, seeking clearance for its Fenom PRO Point-of-Care Breathalyzer.


Asthma diagnosis and care is characterized by products, technologies and procedures that have not changed significantly in decades. Devices such as spirometers offer limited support for clinicians to make better clinical decisions for their patients in terms of initial diagnosis and continuous monitoring of asthmatic conditions. In terms of diagnosis, large numbers of asthmatics (as many as 50% of children, and 33% of adults) reportedly go untreated. Regarding monitoring, there are no solid-state devices to measure airway inflammation.

As recently as September, Spirosure launched its Fenom PRO Point-of-Care Breathalyzer in Europe, as we reported here. The patent-protected, Fractional exhaled Nitric Oxide (FeNO)-based Fenom PRO™ breath analyzer is designed to help patients manage their asthma. Portable and non-invasive, the system uses state-of-the-art technology with proprietary algorithms to detect nanoscopic-sized nitric oxide (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 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.

Physician/advisor comments

“FeNO-monitoring of asthma patients at point of care not only offers great potential to improve asthma therapy but also monitor adherence of controller maintenance medication use, and may reduce the risk of asthma emergency visits and hospitalizations,” explained Randall W. Brown, M.D., pulmonologist and director of asthma and COPD Programs, Center for Managing Chronic Disease, University of Michigan; and a Scientific Advisor to Spirosure. “Also, it’s important to note that the European Respiratory Society is one of several medical professional organizations that has advanced protocols advocating FeNO testing for the assessment, management, and long-term monitoring of asthma.”

Company comments

“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.


Source: Spirosure, Inc.

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