Clear Guide Medical, a healthcare technology company based in Baltimore, announced today that it has received 510(k) clearance from the FDA for its CT-Ultrasound fusion and image guidance system known as SCENERGY.
Sold as an accessory to ultrasound machines, the device uses an integrated display of fused ultrasound and CT images to assist interventional radiologists and surgeons with minimally-invasive biopsies as well as other diagnostic and therapeutic procedures.
"SCENERGY is a real advance for image-guided interventions," said company CTO Philipp Stolka, PhD, in a press release. "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."
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