FDA approves Oridion's breath test device:
This article was originally published in Clinica
The US FDA has approved Oridion Systems' 510(k) application for its BreathID Breath Testing device. The Jerusalem, Israel company says it will begin marketing the device as soon as it obtains FDA approval for the urea tablet that forms part of the device's first application, the 13C urea Helicobacter pylori breath test. The test will enable physicians to diagnose the bacteria in a single office visit, without the need to send samples to a central laboratory.