FDA OKs Bedfont Scientific’s NObreath FeNO monitor

UK-based Bedfont Scientific achieved U.S. Food and Drug Administration (FDA) clearance for its NObreath FeNO monitor to monitor airway inflammation. The portable, non-invasive device measures fractional exhaled nitric oxide (FeNO) in breath. Nitric oxide is often found to be increased in inflammatory ailments like asthma.
 
Interpreting FeNO helps identify patients who do or don’t need ongoing treatment¹. It also differentiates between allergic and non-allergic asthma² and can help predict and prevent exacerbations and attacks³.
 
“NObreath has been available outside the U.S. for over 12 years now, we have been working towards FDA clearance for quite some time and we are over the moon to have received it,” Jason Smith, Managing Director at Bedfont told the press. “We are one step closer to achieving our purpose; to make FeNO monitoring lower cost and therefore more accessible globally. According to the Centre for Disease Control (CDC), around 25 million Americans suffer from asthma; that’s a potential 25 million people that the NObreath can help through FeNO monitoring.”
 
References
¹ Andrew D. Smith, Jan O. Cowan, Sue Filsell, Chris MacLachlan, Gabrielle Monti-Sheehan, Pamela Jackson and D. Robin Taylor. Diagnosing Asthma: Comparisons between Exhaled Nitric Oxide Measurements and Conventional Tests. Am J Respir Crit Care Med Vol 169. pp 473-478, 2004.
₂ Coumou HBel E. Improving the diagnosis of eosinophilic asthma [Internet]. Taylor and Francis online. 2017 [cited 21 December 2021]. Available from: http://www.tandfonline.com/doi/full/10.1080/17476348.2017.1236688
³ Harkins M. Exhaled Nitric Oxide Predicts Asthma Exacerbation [Internet]. Taylor & Francis. 2017 [cited 21 December 2021]. Available from: http://www.tandfonline.com/doi/abs/10.1081/JAS-120033990