The US Food and Drug Administration (FDA) has approved Clear Guide Medical's Scenergy CT-ultrasound fusion and image guidance system.
The Clear Guide Scenergy system operates via an intelligently integrated display of fused ultrasound and CT images. It will be sold as an accessory to ultrasound machines.
The system will allow radiologists and surgeons carry out minimally-invasive biopsies as well as other diagnostic and therapeutic procedures, the company said.
Clear Guide Medical CEO Dorothee Heisenberg said: "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."
The company said it designed the Scenergy as a simpler multi-modality imaging system using ultrasound to reduce the number of CT scans and time consumed in the CT suite.
The system addresses several design and functional challenges associated with the existing fusion CT and ultrasound imaging devices.
The existing fusion systems need long and complex registration processes, while the new system helps in avoiding those steps through its automated registration and robust system fusion that is continuously updated in the entire procedure.
The system features instrument navigation designed to overlay instrument paths during imaging, with the ability to lock in a target and realign the flow from several angles to identify the target.
Clear Guide Medical has not yet received any approval for the Scenergy system outside the US. The company is currently undertaking other international clearances for clinical use.
In April 2015, the company received CE mark approval for its Clear Guide One, which will allow clinical personnel to see the needle or catheter path on the ultrasound display before entering the patient body.
Image: Clear Guide Scenergy attaches to most commercially available ultrasound probes. Photo: courtesy of PRNewsFoto/Clear Guide Medical.