Bedfont Scientific Ltd receives FDA clearance for NObreath® FeNO monitor

Bedfont's NObreath® monitor for airway inflammation has been cleared for sale in the USA

MAIDSTONE, England, Jan. 31, 2022 /PRNewswire/ -- UK, med-tech company, Bedfont Scientific Ltd., is celebrating a brighter 2022 as the U.S. Food and Drug Administration (FDA) cleared its NObreath FeNO monitor for use in monitoring airway inflammation.

The NObreath®, which conforms to ATS and ERS guidelines¹, 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 treatment² whilst also differentiating between allergic (eosinophilic) and non-allergic asthma³, and if used daily, FeNO measurements can help to predict and prevent exacerbations and attacks⁴.

Jason Smith, Managing Director at Bedfont, comments, "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."

REFERENCES

1. ATS/ERS Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide, 2005; American Journal of Respiratory and Critical Care Medicine; vol. 171: 912-930;2005
2. 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.
3. 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
4. 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

COMPANY DETAILS:

Managing Director: Mr Jason Smith
Registered Office: Station Yard, Station Road, Harrietsham, Maidstone, Kent, ME17 1JA, United Kingdom
Company Registration No: 1289798 (England & Wales)
Website: www.bedfont.com

Established in 1976, Bedfont® Scientific Limited is a second-generation family company that has specialised in the design and manufacture of exhaled breath and gas monitoring instruments for medical applications, globally, for over 40 years. Bedfont® is revered as a pioneer in the breath analysis market with their products now available in over 76 countries across the world thanks to their unprecedented network of appointed distributors. Their aim is to continue innovating and improving health worldwide.

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