New SCENERGY Ultrasound-CT Fusion System gets USFDA clearance

BALTIMORE:  Clear Guide Medica has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market innovative CT-Ultrasound fusion and image guidance system, the Clear Guide SCENERGY. This device is aimed at helping 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 multi-modality 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.

"SCENERGY is a real advance for image-guided interventions," said Dr. Philipp Stolka, CTO of Clear Guide Medical. "Because SCENERGY is installed onto existing equipment, it can quickly be adopted in many different locations, benefitting patients sooner. We believe that its unique dynamic registration approach solves many problems that hindered the adoption of other guidance technologies."

Clear Guide Medical designed SCENERGY 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 burdensome step through automated registration and robust 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 Dr. Joseph Fonte of Brigham and Women's Hospital in Boston, MA. "This is a game-changer."

Adding to SCENERGY's simplicity is the intuitive instrument navigation that 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.

"We have pioneered solutions like our real-time CT-ultrasound fusion technology to provide all users with better image clarity and real-time CT visualization," said Dorothee Heisenberg, CEO of Clear Guide Medical. "SCENERGY is evidence of our commitment to transforming healthcare through innovations that enable best-in-class minimally-invasive procedures at an affordable price."

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.