February 16, 2016 — Clear Guide Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its computed tomography (CT)-ultrasound fusion and image guidance system, the Clear Guide Scenergy. The 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.
Working in collaboration with partner hospitals, Scenergy was developed in response to a clear need for simpler multimodality imaging using ultrasound while minimizing the number of CTs and time spent in the CT suite. 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. Best of all, Scenergy does not require special needles or new imaging equipment, preserving the customary workflow and maximizing the productivity of existing capital equipment.
Clear Guide Medical designed the device to address the myriad challenges associated with working with CT and ultrasound images simultaneously. Current fusion systems require long and complex registration processes. Scenergy eliminates this step through automated registration and system fusion, which is continuously updated throughout the procedure. The time required for registration drops to seconds. Moreover, clinical recommendations to reduce CT radiation doses heighten the importance of good ultrasound visualization. With CT precisely overlaid on the ultrasound plane, deep and challenging lesions can be visualized and targeted efficiently.
"The ability to see my target lesion clearly before, during and after a procedure means procedures can be reliably performed in ultrasound with real-time imaging, freeing up the CT suite for diagnostic imaging and mitigating exposure to ionizing radiation for the patient and staff," said Joseph Fonte, M.D., of Brigham and Women's Hospital in Boston. "This is a game-changer."
The intuitive instrument navigation overlays the path of standard instruments on the imaging. The ability to lock in a target, then realign the probe from a different angle and find that target with precision can be helpful in a number of situations.
The Scenergy is not yet available for sale outside the United States. Clear Guide Medical is currently pursuing other international clearances for clinical use. A research system was already installed in the National Institutes of Health (NIH) Center for Interventional Oncology.
For more information: www.clearguidemedical.com