The company has developed a catheter for imaging the coronary arteries.
Topspin Medical Inc. (TASE:TOPMD) has received FDA approval to start conducting clinical trials in the US with its advanced generation IntraVascular MRI (IVMRI) catheter, intended for the detection and characterization of lesions in the coronary arteries.
Up until now the company conducted clinical trials with its IVMRI catheter in Europe and Israel, and following the FDA approval TopSpin intends to extend the clinical trials to leading US clinical sites.
The data collected in the clinical trials will be submitted to the regulatory authorities in Europe and the US for the applications for market approval in these territories.
TopSpin expects that it will receive the CE Mark for marketing the product in Europe by the end of 2006, and FDA marketing approval in the US by the middle of 2007.
Published by Globes [online], Israel business news - www.globes.co.il - on June 28, 2006
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