No Carolina / NY / Florida
Ph: 561.316.3330

No Carolina | NY | Florida

Bedfont Scientific Ltd receives FDA clearance for NObreath® FeNO monitor

Editor: What To Know

  • 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.
  • 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.

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: https://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: https://www.tandfonline.com/doi/abs/10.1081/JAS-120033990
Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Recent News

CV Societies Propel Plans Forward for a New Board of Cardiovascular Medicine

“The open comment period is the time for cardiovascular physicians, allies in other medical specialties, patients, and others to make their voices heard on why an independent CV Board is the best path for cardiologists to stay up-to-date on best practices and evidence-based care, ensuring patients receive the best possible care,” said Jeffrey Kuvin, MD, president of the proposed Board’s new Board of Directors. “The field of cardiovascular medicine has evolved dramatically over the past few decades; now is the right time to develop an independent cardiovascular Board.”

Hyundai Bioscience Announces Clinical Development Plan for Niclosamide-based Metabolic Anticancer Drug Targeting P53 Mutation Cancer

Sang-ki Oh, CEO of Hyundai Bioscience, stated, "Niclosamide-based metabolic anticancer drug candidate will be the first P53-targeting anticancer treatment that selectively kills p53 mutated cancer cells," and added, "Through our subsidiary ADM Korea, we plan to conduct clinical trials targeting cancer patients with intractable cancer caused by p53 mutations, which will be the first step of clinical development on niclosamide-based anticancer agent pipeline."

Sedana Medical Completes Patient Recruitment for INSPiRE-ICU 1 Clinical Trial in the US

Peter Sackey further elaborated: "Once the 30-day follow-up of all patients is complete, we will enter into an intense phase of final monitoring, data cleaning and transfer to our statistician team for analysis. In parallel, the long-term outcomes at 3 and 6 months will be collected centrally by the Critical Illness, Brain Dysfunction, and Survivorship team at Vanderbilt Medical Center. With this parallel approach, we expect topline results in the autumn of this year and a swift regulatory submission in Q1, 2025".

Health / Lifestyle

Articles of Interest

Stay Connected

spot_img

About Medical Device News Magazine

About Medical Device News Magazine. A digital publication founded in 2008 located in the United States. The publication is one of the industry’s leading sources of medical device and biotech industry updates. Medical Device News Magazine is easily accessible 24/7/365 and is a fast 1, 2, 3 easy read! Our purpose is...

By using this website you agree to accept Medical Device News Magazine Privacy Policy