Technology | Fusion Imaging Software | February 16, 2016

Clear Guide Medical Wins FDA Clearance for Scenergy Ultrasound-CT Fusion System

Clinical device provides real-time fusion for interventional procedures on existing ultrasound machines

Clear Guide Medical, Scenergy ultrasound-CT fusion system, FDA clearance

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

Related Content

Iodine-based CT contrast ready for scanning with a Canon Aquilion One 320-slice CT system at Northwestern Medicine Central DuPage Hospital in the Chicago suburbs.
News | Radiology Imaging | January 22, 2020
January 22, 2020 — The risk of administering modern...
This is a lung X-ray reviewed automatically by artificial intelligence (AI) to identify a collapsed lung (pneumothorax) in the color coded area. This AI app from Lunit is awaiting final FDA review and in planned to be integrated into several vendors' mobile digital radiography (DR) systems. Fujifilm showed this software integrated as a work-in-progress into its mobile X-ray system at RSNA 2019. GE Healthcare has its own version of this software for its mobile r=ray systems that gained FDA in 2019.   #RSNA #

This is a lung X-ray reviewed automatically by artificial intelligence (AI) to identify a collapsed lung (pneumothorax) in the color coded area. This AI app from Lunit is awaiting final FDA review and in planned to be integrated into several vendors' mobile digital radiography (DR) systems. Fujifilm showed this software integrated as a work-in-progress into its mobile X-ray system at RSNA 2019. GE Healthcare has its own version of this software for its mobile r=ray systems that gained FDA in 2019.

Feature | RSNA | January 20, 2020 | Dave Fornell, Editor
Here are images of some of the newest new medical imaging technologies displayed on the expo floor at the ...
Videos | RSNA | January 13, 2020
ITN Editor Dave Fornell takes a tour of some of the most innovative new medical imaging technologies displayed on the
Sponsored Content | Videos | Ultrasound Imaging | January 06, 2020
The Arietta 850SE provides facilities with numerous features and functionality to get the most out of a system.
Sponsored Content | Videos | Computed Tomography (CT) | January 06, 2020
Hitachi announced the FDA clearance of its newest CT – Scenaria View – at RSNA2019.
Sponsored Content | Videos | Computed Tomography (CT) | January 03, 2020
In this Conversations video at AHRA, Ryan K.
Videos | Advanced Visualization | December 30, 2019
This is a hologram of a fracture from a...
This is artificial intelligence on Fujifilm's mobile digital radiography system to immediately detect pneumothorax (a collapsed lung) and show the location to the technologist and attending physician in a unit before the image is even uploaded to the PACS for a read. AI applications like this that have immediate impact on critical patient care saw a lot of interest at RSNA 2019.

This is work-in-progress artificial intelligence app on Fujifilm's mobile digital radiography system to immediately detect pneumothorax (a collapsed lung), The AI highlights the area of interest to show the location to the technologist and attending physician in a unit before the image is even uploaded to the PACS for a read by a radiologist. The technology also can flag the study for an immediate read in the PACS worklist for confirmation by a human. This technology is from a third-party and will be offered on Fujifilm's REiLI AI platform. Applications like this that have immediate impact on critical patient care saw a lot of interest at RSNA 2019. Photos by ITN Editor Dave Fornell.

Feature | Artificial Intelligence | December 27, 2019 | Siddharth Shah and Srikanth Kompalli, Frost & Sullivan
Radiology artificial intelligence (AI) was again the hottest topic at the 2019...