Clear Guide Medical wins 510(k) for Scenergy image guidance

Clear Guide Medical said today it won FDA 510(k) clearance for its Scenergy CT-Ultrasound fusion and image guidance system designed to aid in minimally invasive biopsies and other diagnostic and therapeutic procedures.

The system operates through an intelligently integrated display of fused ultrasound and CT images, and will be sold as an accessory to ultrasound machines, the Baltimore, Md.-based company said.

“Scenergy is a real advance for image-guided interventions. 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,” CTO Dr. Philipp Stolka said in prepared remarks.

Clear Guide Medical said it designed the Scenergy as a simpler multi-modality imaging system using ultrasound to minimize the number of CT scans and time spent in the CT suite. The company said its device addresses certain design and functional challenges associated with existing fusion CT and ultrasound imaging devices.

“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. This is a game-changer,” Dr. Joseph Fonte of Boston’s Brigham and Women’s Hospital said in a press release.

The system features “intuitive instrument navigation” designed to overlay instrument paths during imaging, as well as the ability to lock in a target and realign the probe from different angles to find the target.

“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. Scenergy is evidence of our commitment to transforming healthcare through innovations that enable best-in-class minimally-invasive procedures at an affordable price,” CEO Dorothee Heisenberg said in a prepared statement.

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