{"id":183,"date":"2018-02-19T10:46:00","date_gmt":"2018-02-19T10:46:00","guid":{"rendered":"https:\/\/www.bedfont.com\/wp\/?p=183"},"modified":"2018-02-19T10:46:00","modified_gmt":"2018-02-19T10:46:00","slug":"bedfont-scientific-ltd-makes-toxco-fda-510k-submission","status":"publish","type":"post","link":"https:\/\/www.bedfont.com\/de\/bedfont-scientific-ltd-makes-toxco-fda-510k-submission\/","title":{"rendered":"Bedfont Scientific Ltd. makes ToxCO\u00ae FDA 510(k) submission"},"content":{"rendered":"\n<p><strong><em>Bedfont Scientific Ltd. has made a 510(k) submission for US  FDA clearance of their ToxCO\u00ae monitor used by emergency services to mass  screen for carbon monoxide (CO) poisoning.<\/em><\/strong><\/p>\n\n\n\n<p>Bedfont, based in the UK, specialists in the design and manufacture \nof breath analysis medical products, has made an FDA 510(k) submission \nfor clearance to sell one of its breath analysers, the ToxCO\u00ae.<\/p>\n\n\n\n<p>Established in 1976, the second-generation family company already \nhas one device on the market in America, their Micro+&#x2122; Smokerlyzer\u00ae CO \nmonitor to help people quit smoking. Using a similar technology, the \nToxCO\u00ae is designed for emergency services to mass screen for cases of CO\n poisoning, providing a quicker method than the traditional blood test. A\n breath sample can be taken from a patient via mouthpiece, or in \ninstances where the patient is unconscious, by face mask. By being able \nto mass screen patients on-site, it can rule out unnecessary hospital \nadmissions and save valuable time, furthermore, the ToxCO\u00ae has ambient \nmonitoring which begins from switch-on, alerting emergency services to \nhigh levels of atmospheric CO at the scene of the incident, helping to \nsafeguard them and be prepared.<\/p>\n\n\n\n<p>Known as the silent killer, CO is a colourless, odourless, highly \npoisonous gas that is produced when fuels are burned incompletely. \nEverybody is exposed to CO in everyday life; from boilers, open fires, \ncars, generators and even burning your toast. CO poisoning is the most \ncommon type of fatal poisoning in many countries1. According to the CDC,\n \u201cduring 1999\u20132010, a total of 5,149 deaths from unintentional carbon \nmonoxide poisoning occurred in the United States, an average of 430 \ndeaths per year\u201d.2 Prolonged exposure can lead to severe health \nconsequences, and if exposed for too long, death.&nbsp;An exposure to \n12,800ppm of carbon monoxide can kill you within 1-3 minutes3. <\/p>\n\n\n\n<p><strong>Jason Smith, Managing Director at Bedfont, explains, <\/strong>\u201cWe\n are working hard to help raise awareness of breath analysis in the USA \nand how the ToxCO\u00ae has the potential to save so many lives. We are fully\n committed to working closely everyone involved to have swift and \nsuccessful FDA clearance for this product.\u201d<\/p>\n\n\n\n<p><strong>Daniel Sibis, Vice President at coVita LLC, <\/strong>Bedfont\u2019s\n USA distributor, comments, \u201cThe ToxCO\u00ae will revolutionise how emergency\n services approach carbon monoxide poisoning. Compared to blood samples,\n breath analysis with the ToxCO\u00ae is quick, easy and completely \nnon-invasive. This means no more needles and with values shown instantly\n onscreen, the ToxCO\u00ae will save more lives.\u201d<\/p>\n\n\n\n<p><strong>PLEASE NOTE: <\/strong>The ToxCO\u00ae is not available for sale in the U.S.A at this time.<\/p>\n\n\n\n<p>-ends-<\/p>\n\n\n\n<p><strong>REFERENCES<\/strong><\/p>\n\n\n\n<p>1.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Humber, A. (2009) \u2018A Feasibility study into the prehospital\n carbon monoxide poisoning of patients\u2019, London Ambulance Service NHS.<\/p>\n\n\n\n<p>2.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;QuickStats: Average Annual Number of Deaths and Death Rates\n from Unintentional, Non\u2013Fire-Related Carbon Monoxide Poisoning,*\u2020 by \nSex and Age Group \u2014 United States, 1999\u20132010 [Internet]. Cdc.gov. 2018 \n<\/p>\n\n\n<p>[cited 11 January 2018]<\/p>\n\n\n\n<p>. Available from: <a href=\"https:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/mm6303a6.htm\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/mm6303a6.htm<\/a><\/p>\n\n\n\n<p>3.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;CO Health Risks &#8211; Detect Carbon Monoxide [Internet]. Detect\n Carbon Monoxide. 2017 [cited 17 January 2018]. Available from: <a href=\"http:\/\/www.detectcarbonmonoxide.com\/co-health-risks\/\" target=\"_blank\" rel=\"noreferrer noopener\">http:\/\/www.detectcarbonmonoxide.com\/co-health-risks\/<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Bedfont Scientific Ltd. has made a 510(k) submission for US FDA clearance of their ToxCO\u00ae monitor used by emergency services to mass screen for carbon monoxide (CO) poisoning. Bedfont, based in the UK, specialists in the design and manufacture of breath analysis medical products, has made an FDA 510(k) submission for clearance to sell one [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":184,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-183","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Bedfont Scientific Ltd. makes ToxCO\u00ae FDA 510(k) submission - Bedfont Scientific Ltd.<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.bedfont.com\/de\/bedfont-scientific-ltd-makes-toxco-fda-510k-submission\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bedfont Scientific Ltd. makes ToxCO\u00ae FDA 510(k) submission - Bedfont Scientific Ltd.\" \/>\n<meta property=\"og:description\" content=\"Bedfont Scientific Ltd. has made a 510(k) submission for US FDA clearance of their ToxCO\u00ae monitor used by emergency services to mass screen for carbon monoxide (CO) poisoning. 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