The intravascular MRI catheter won European marketing approval a few months ago.
Topspin Medical Inc. (TASE:TOPMD) has applied to the US Food and Drug Administration (FDA) for marketing approval for the company’s first-generation imaging intravascular MRI (IVMRI) catheter. The company has completed laboratory tests, preclinical and clinical trials for the catheter.
Topspin CEO Yaron Tal said, “We’re pleased to announce that we’ve applied to the FDA for marketing approval for the IVMRI catheter in the US after completing all the tests and trials necessary for the application. FDA approval will give the company access to the US market, which is the largest market in the world for invasive cardiology procedures.”
In July, Topspin signed a distribution agreement for the IVMRI with Johnson & Johnson Israel, under an exclusive three-year contract. Topspin did not disclose the terms of this contract. The IVMRI catheter won EU CE Mark approval a few months ago.
Published by Globes [online], Israel business news - www.globes.co.il - on October 7, 2007
© Copyright of Globes Publisher Itonut (1983) Ltd. 2007