Thursday, April 3, 2008
BreathID Sniffs Success, Eyes FDA Approval
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Medgadget readers might recall our May, 2006 coverage of the BreathID® System, an electronic breath analysis device designed to evaluate overall liver function in patients with chronic hepatic diseases, such as hepatitis or cirrhosis. According to the latest report in the Globes:
Exalenz Bioscience Ltd. has applied to the US Food and Drug Administration (FDA) for marketing approval of the company's BreathID device following completion of a clinical trial on 500 patients.The trial was conducted at Hadassah Medical Organization in Ein Kerem, Kings College in London, and in Zurich. The trial aimed at diagnosing liver damage caused by cirrhosis and hepatic impairment. The BreathID diagnostic device achieved 90% accuracy compared with biopsies, which are considered the "gold standard".
Going back to the basics, here's an overview of the BreathID technology:
The BreathID System is a revolutionary platform capable of assessing a range of liver and gastrointestinal disorders via molecular analysis of the patient's exhaled breath. The system is the only breath-testing technology that provides continuous, automatic and real-time patient monitoring and data analysis. BreathID uses a clinically proven, sophisticated laser-like light source to pinpoint real-time changes in 13C/12C isotope ratios at an accuracy level of single parts per million. It is a paradigm change in the way liver and GI disorders are assessed and managed. Covered by more than 60 patents and patent applications worldwide, the BreathID system is one of the most versatile and advanced diagnostic platforms for hepatologists and gastroenterologists in today`s medical environment.BreathID® is a proven, breath-testing system that incorporates a number of proprietary core technologies - such as Microstream®, MCS™ (Molecular Correlation Spectroscopy), CRT™ (Continuous Real Time) and online analysis algorithms that are protected by a series of patents and patent applications.
The BreathID combination of advanced technologies allows for automatic, continuous and real-time breath sampling and analysis. This ensures highly accurate results and the shortest possible test duration. Moreover, the system is portable so that tests can be conducted in any clinical setting.
BreathID Technology Process
Product page: BreathID Technology...
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