UK medtech company Bedfont Scientific has received U.S. Food and Drug Administration (FDA) clearance for its NObreath FeNO monitor for use in monitoring airway inflammation.
The NObreath, which conforms to ATS and ERS guidelines, is a portable, non-invasive device for the measurement of Fractional Exhaled Nitric Oxide (FeNO) in human breath. The production of nitric oxide is often found to be increased in inflammatory conditions such as asthma.
The NObreath works by measuring FeNO through breath analysis, making the process quick, simple, and non-invasive for both the healthcare professional and the patient. Interpreting FeNO levels aids in identifying patients who do/do not require ongoing treatment whilst also differentiating between allergic (eosinophilic) and non-allergic asthma, and if used daily, FeNO measurements can help to predict and prevent exacerbations and attacks.
Jason Smith, managing director at Bedfont, said: “NObreath has been available outside the US 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. 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.”
