Spirosure Fenom Pro Asthma Monitor Cleared

FDA has cleared a Spirosure 510(k) for its Fenom Pro Asthma Monitor for use by allergists, immunologists and pulmonologists to help patients manage asthma by measuring the fraction of exhaled nitric oxide (FeNO) in their patients’ breath. FeNO is an established biomarker for airway inflammation in human exhaled breath, the company says. “Measurement of FeNO by Fenom Pro is a method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy as an indication of therapeutic effect in patients with elevated FeNO levels,” it says.

The device uses proprietary algorithms to detect exhaled nitric oxide molecules in concentrations of parts per billion in human breath, Spirosure says. The measurement is intended to occur at the point of care where a patient exhales at a slow rate for 10 seconds to generate results in less than 30 seconds.