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.
The medical device manufacturer has made an FDA 510(k) submission for clearance to sell breath analyser the ToxCO.
Established in 1976, the second-generation family company already has one device on the market in America, their Micro+™ Smokerlyzer® CO monitor to help people quit smoking. Using a similar technology, the ToxCO can instantly diagnose CO poisoning by analysing a breath sample from the patient to determine the level of CO in their blood.
The ToxCO monitor is a non-invasive tool, which provides instant results unlike more traditional methods of testing for CO poisoning, like blood testing, saving valuable time when diagnosing a patient. The ToxCO also comes with a face mask option for unconscious patients, and an ambient air mode designed for emergency services and first responders.
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”.
Bedfont’s Managing Director Jason Smith explained, “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.”