A new intravascular MRI catheter developed by Topspin Medical has received CE Mark approval, and the Israeli company expects to obtain FDA approval within the first half of 2007.
The device is designed for examining fatty build-up in coronary arteries, providing a detailed image of internal tissues. The IVMRI is a second-generation product that further miniaturized imaging systems and combines a greater number of sensors for imaging a larger area.
Even before obtaining CE Mark approval, the company signed a distribution agreement for the IVMRI with Top Medical BV in the Benelux.