FDA clears 3-D EchoTech add-on

The Food and Drug Administration has granted 510(k) marketing clearance to 3-D EchoTech for the German company's 3-D FreeScan module, which enables conventional ultrasound scanners to create 3-D images. The Munich-based company plans to begin selling the device immediately via direct sales and through OEMs, with a list price of around $19,500, not including computer.

The 3-D FreeScan module consists of an electromedical sensor that attaches to a standard ultrasound probe. It enables sonographers to use freehand scanning methods to collect 3-D data, rather than stepping motors or other mechanical devices. Three-D images are processed and reconstructed on Pentium-class PCs in about 40 seconds. Once reconstructed, the images can be manipulated and rotated in real time, according to Ricardo Cabrera, director of sales and marketing for the Americas region.

The FDA clearance covers radiology applications of 3-D FreeScan, as well as neurology, peripheral vascular, and urology applications. The company is preparing a 510(k) application for a version of the technique that uses an ECG trigger to collect cardiac images. It displayed the technique at the American Society of Echocardiography in San Francisco this month.