News | Press Releases

November 28, 2007

TOSHIBA'S AquilionONE RECEIVES FDA CLEARANCE

With 510K Clearance, the New Dynamic Volume Computed Tomography System is on Schedule for Commercial Availability in 2008

CHICAGO, Nov. 27 , 2007 - Toshiba America Medical Systems, Inc. a leader in diagnostic and medical imaging today announced FDA clearance of the most advanced diagnostic imaging equipment available - the AquilionONE™. With this clearance, Toshiba is on schedule to make the system commercially available in summer, 2008. This dynamic volume computed tomography system revolutionizes patient care by reducing diagnosis time for life threatening diseases like stroke and heart disease from days and hours to mere minutes.

For the first time, physicians can see not only a three-dimensional depiction of an organ, but also the organ's blood flow and dynamic function. Unlike any other CT system, the AquilionONE can scan one organ - including heart, brain and other organs - in one rotation because it covers maximum 16cm of anatomy. This reduces exam time as well as radiation and contrast dose and provides dramatically more accurate diagnoses because the organ is captured in a single rotation at one moment in time, eliminating the need to reconstruct slices from multiple points in time.

"Dynamic volume CT marks a monumental leap in diagnostic imaging drastically improving physicians' ability to diagnose serious diseases faster and more safely while reducing healthcare costs," said Doug Ryan, senior director, CT Business Unit, Toshiba.

"Receiving FDA clearance is a significant step toward making this advanced technology available to the medical community and we look forward to its availability in 2008."

*AquilionONE™ is a trademark of Toshiba Medical Systems Corporation