Newswatch: March 2006

FDA Approved!

Swissray International (Elizabeth, NJ) has received FDA 510(k) clearance to market its new direct DR system, the ddRFormula. The new system features a C-arm design and incorporates Swissray's patent-pending FP-5000 detector. Incorporated in the ddRFormula is Trixell's 17- x 17-inch amorphous silicon TFT flat panel that features infrared collision avoidance, coupled with a proactive shock-absorption system for maximum detector protection. The FP-5000 detector delivers exceptional diagnostic image quality with very low radiation dose and very high detail detectability.

Xoft Inc (Fremont, Calif) has received FDA clearance for its Axxent Electronic Brachytherapy System for the treatment of breast cancer. Electronic brachytherapy is a proprietary technology platform designed to deliver localized, nonradioactive, isotope-free radiation treatment in a minimally shielded clinical setting under the supervision of a radiation oncologist. The Axxent system uses disposable micro-miniature X-ray radiation sources to deliver ionizing radiation treatment directly to tumor beds. In its first indication for use, the Axxent system can be used to deliver a course of radiation therapy for early-stage breast cancer. It gives radiation oncologists the flexibility to deliver radiation at multiple energy levels, while eliminating the need for heavily shielded environments so that it can be used in a broader range of clinical settings. Patients can now choose breast-sparing lumpectomy surgery with adjuvant radiation therapy over the alternative of a full mastectomy.