Israel's Oridion gets FDA clearance for breath testing device

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Last Updated: 2001-07-20 15:27:19 EDT (Reuters Health)

WASHINGTON (Reuters Health) – Oridion Systems Ltd. has received clearance from the US Food and Drug Administration to market a noninvasive testing device that detects Helicobacter pylori in a single office visit, the Israeli medical device maker said on Thursday.

Oridion said it received clearance to market its patented BreathID testing device, a unit designed to screen the status of organ specific medical conditions at the point of care.

The company added that it expects a strong response because of the expressed need by doctors for a noninvasive, rapid method to detect peptic ulcers that might lead to gastric cancer.

Oridion said it cannot begin distributing the device until the FDA also clears the urea tablet that is a part of the breath test. The company already has begun to seek the approval of the BreathID testing device in Europe and Japan.

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