Bedfont Receives FDA Clearance for ToxCO Breath Analyzer to Monitor Blood Carbon Monoxide Levels

VCBeat (WeChat ID: vcbeat) has learned that Bedfont, a medical device company, recently received U.S. Food and Drug Administration (FDA) clearance for its ToxCO breath analysis monitor, which is designed to detect carbon monoxide levels in the blood. Bedfont announced that it has entered into an exclusive distribution agreement with CoVita for the U.S. market.

Bedfont, established in 1976 and headquartered in Kent, UK, is a medical device company. As a pioneer in the respiratory analysis market, the company has been committed to developing globally leading medical gas detection equipment. In 2015, it completed a €500,000 financing round. Despite being a small family-owned business with just over 40 employees, the company boasts a robust distributor network, with export sales accounting for 80% of its total turnover in 2018.

Bedfont offers a range of products, including the NObreath fractional exhaled nitric oxide (FeNO) monitor, which measures airway inflammation and response to antibiotic therapy, holding significant importance for the treatment of asthma and other respiratory diseases; the Smokerlyzer carbon monoxide monitor, which helps patients quit smoking and reduces the risk of smoking-related diseases; and the Gastrolyzer gastrointestinal hydrogen breath tester, which detects gastrointestinal disorders by measuring the concentration of hydrogen in exhaled breath. These products are sold in more than 70 countries and regions worldwide, including China.

It is understood that carbon monoxide is a common, colorless, odorless, and non-irritating toxic gas. After entering the body, a portion of carbon monoxide binds to hemoglobin, significantly reducing its oxygen-carrying capacity, while another portion directly binds to cytochrome a3 within the mitochondria of cells, inhibiting cellular respiration. Therefore, excessive inhalation poses a fatal risk.

The ToxCO Breath Analyzer screens for carbon monoxide poisoning by monitoring the level of carbon monoxide in exhaled breath. Unlike traditional testing methods, this device offers rapid, simple, non-invasive, and non-contact operation. Patients can complete sampling with a single breath into the device’s mouthpiece, while those lacking consciousness can be sampled using a face mask.

The ToxCO breath analyzer displays test results on its touchscreen within 20 seconds, while automatically archiving the data for easy access by healthcare professionals. This device thus saves critical time in emergency care and helps save patients’ lives. Additionally, the ToxCO breath analyzer can monitor ambient carbon monoxide levels and issues an alarm when users enter areas with high carbon monoxide concentrations.

(Compiled by Jiao Yanli)