Radionics Announces FDA Clearance for 2 Modules of its Image-Guided Neurosurgery System, For a Total of 11 Clearances Since June 1997.

BURLINGTON, Mass.--(BW HealthWire)--July 9, 1998--Today Radionics' Software Applications division announced 510(k) clearance for the Universal Instrument Registration and Microscope modules of its Optical Tracking System (OTS(R)). This system is used for image-guided surgical procedures. This brings the total of FDA clearances for Radionics to 11 since June 1997.

The Optical Tracking System is a clinically proven system that provides a complete surgical navigation solution for cranial and spinal procedures. The OTS quickly and precisely matches a patient to their preoperative image scans and enables the surgeon to track various instruments in and around the patient anatomy. The instrument location, both tip and trajectory, is then displayed in numerous interactive 2D and 3D views of the patient anatomy.

With the Universal Instrument Registration (UIR) module of the system, the surgeon is able to register and track a wide variety of instruments in the surgical field. The OTS calibrates the instrument tip and trajectory before each use, which ensures optimal tracking accuracy for each procedure regardless of the instrument geometry. The OTS is the only system that offers the ability to track nearly any instrument on the fly, both tip and trajectory.

The Microscope module of the OTS offers surgeons the ability to combine the precision optics of almost any major model surgical microscope with the localization power of image guidance. The OTS quickly calibrates the fixed focal point and trajectory of the microscope, and the information is correlated to the patient scan images and updated interactively during surgery. Radionics has al so signed collaborative agreements with leading microscope manufacturers, such as Carl Zeiss and Moller-Wedel. This will ensure a seamless interface between the microscope and the OTS.

"The flexibility of the OTS has been greatly enhanced with this FDA clearance. Now, surgeons are able to select the instruments they wish to use for image guided tracking, including the microscope. Since each patient procedure is unique, this versatility is especially important," stated Michael Williams, Ph.D, President of Radionics Software Applications.

Radionics, the worldwide leader in stereotactic surgery, has been mapping the future of medical technology by producing innovative surgical devices since 1938. Other products include the XKnife(R) Radiosurgery/Stereotactic Radiotherapy System, StereoPlan(R) Stereotactic Planning Software, ImageFusion(TM), and others. These products are being used successfully at 350+ sites worldwide.

CONTACT: Radionics Marketing department

800/466-6814 or 781/272-1233.