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Bedfont Scientific Ltd. makes ToxCO® FDA 510(k) submission
Bedfont Scientific Ltd. has made a 510(k) submission for US FDA clearance of their ToxCO® monitor used by emergency services to mass screen for carbon monoxide (CO) poisoning.
By: Bedfont Scientific Ltd.
Established in 1976, the second-generation family company already has one device on the market in America, their Micro+™ Smokerlyzer®
Known as the silent killer, CO is a colourless, odourless, highly poisonous gas that is produced when fuels are burned incompletely. Everybody is exposed to CO in everyday life; from boilers, open fires, cars, generators and even burning your toast. CO poisoning is the most common type of fatal poisoning in many countries1. According to the CDC, "during 1999–2010, a total of 5,149 deaths from unintentional carbon monoxide poisoning occurred in the United States, an average of 430 deaths per year".2 Prolonged exposure can lead to severe health consequences, and if exposed for too long, death. An exposure to 12,800ppm of carbon monoxide can kill you within 1-3 minutes3.
Jason Smith, Managing Director at Bedfont, explains, "We are working hard to help raise awareness of breath analysis in the USA and how the ToxCO® has the potential to save so many lives. We are fully committed to working closely everyone involved to have swift and successful FDA clearance for this product."
Daniel Sibis, Vice President at coVita LLC, Bedfont's USA distributor, comments, "The ToxCO® will revolutionise how emergency services approach carbon monoxide poisoning. Compared to blood samples, breath analysis with the ToxCO® is quick, easy and completely non-invasive. This means no more needles and with values shown instantly onscreen, the ToxCO® will save more lives."
PLEASE NOTE: The ToxCO® is not available for sale in the U.S.A at this time.
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