TomoTherapy Receives FDA 510(k) Clearance for TomoDirect™ Radiotherapy Technology

MADISON, Wis. – August 26, 2008 – TomoTherapy Incorporated (NASDAQ: TOMO) today announced that it has received FDA 510(k) clearance for its TomoDirect™ radiation therapy technology. TomoDirect is an innovative new discrete-angle, sliding-beam delivery mode for the Hi·Art® treatment system. With this capability, clinicians gain an efficient complement to helical TomoTherapySM, one that enables fast treatment planning and delivery, while broadening the spectrum of patients that can be optimally treated with the industry’s most advanced platform for cancer care.

“This is a major milestone for TomoTherapy and, in turn, for cancer centers of all sizes,” said Fred Robertson, CEO of TomoTherapy. “TomoDirect significantly improves the throughput of our system, and widens the TomoTherapy treatment options available for clinical use. Now, more cancer patients can benefit from true, next-generation treatment technology.”

source: TomoTherapy