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Radionics Announces FDA Clearance of its Spinal Image Guided Surgery Application

BURLINGTON, Mass. (BW HealthWire) Friday, April 24 -- Today Radionics announced 510(k) clearance of the spinal application of its image-guided surgery system, the Optical Tracking System (OTS(R)).

The Optical Tracking System is a clinically proven system providing the complete surgical navigation solution. With versatility and ease-of-use in mind, 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.

Software and hardware advances in the OTS spinal application allow the surgeon to localize the spinal column and to track surgical instruments during the procedure. The application software offers numerous benefits for the spine surgeon for multiple level surgery and preoperative trajectory planning. A compact, lightweight reference frame automatically tracks patient movement during the course of surgery and updates the images on the screen accordingly. Its versatile design allows a range of orientations to minimize intrusion into the surgical field.

"The Optical Tracking System spine module complements the wide range of surgical applications addressed by the OTS platform. As a pioneer in stereotactic image guided surgery, Radionics is committed to developing products to assist surgeons by providing exciting advances in visualization and accuracy. Thanks in part to excellent clinical investigators, we believe the OTS spine module will be an extremely valuable tool for our customers," stated Eric Cosman, Chief Executive Officer of Radionics.

The Optical Tracking System was cleared for cranial applications in June 1997, including ENT surgeries.

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(tm) Stereotactic Planning Software, ImageFusion, and others. These products are being used successfully at 350+ sites worldwide.

For more information, please contact the Radionics Marketing department at (800) 466-6814.

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