Oridion Medical 510(k) for Breath ID test system for H. pylori planned for mid-1998.
This article was originally published in The Gray Sheet
Executive Summary
ORIDION MEDICAL BREATH ID TEST SYSTEM FOR H. PYLORI 510(K) SUBMISSION is anticipated in May or June of 1998, the firm says. The privately held company is currently conducting clinical trials of the non-invasive, point-of-care device in Germany and Israel. Jerusalem-based Oridion, which changed its name from Spegas Industries in November for "more global appeal" and to better reflect its core medical technology, anticipates international sales to commence in the second quarter of 1999.