FDA gives 510(k) approval for Scenergy CT-Ultrasound fusion and image guidance system- Clear Guide Medical

Clear Guide Medical has received 510(k) clearance from the FDA to market its innovative CT-Ultrasound fusion and image guidance system, the Clear Guide Scenergy. This device helps interventional radiologists and surgeons perform minimally-invasive biopsies and other diagnostic and therapeutic procedures through an intelligently integrated display of fused ultrasound and CT images. The system is sold as an accessory to most ultrasound machines.

By showing the clarity of CT with the real-time visualization of ultrasound, users experience the benefits of both modalities simultaneously. Procedure duration will drop with Scenergy's fully automated registration process. Additionally, Scenergy does not require special needles or new imaging equipment, preserving the customary workflow and maximizing the productivity of existing capital equipment.