FDA clears CT-Guide Needle System

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The FDA has approved ActiViews’ CT-Guide Needle Guidance System for Lung interventions. The system is an accessory for CT scanners and is designed to assist physicians during CT-guided interventional procedures.

ActiViews’ CT-Guide system allows physicians to locate interventional instruments in relation to pre-acquired CT images, ActiView stated. It uses a miniature video camera affixed to standard interventional instruments, a sterile registration patch and proprietary 3D software that is viewed on an HD flat panel monitor.

ActiViews concluded a confirmatory safety and effectiveness clinical trial in February at four hospitals in Canada, which yielded 100 percent success at primary endpoints, according to the company.

“With over 100 cases performed at our institution, we demonstrated that CT-Guide navigation could be used in tandem with a conventional coaxial needle biopsy system. We also experienced fewer biopsy needle redirects and check CT scans during the procedure, reflecting increased confidence by the interventional radiologists,” said Kieran Murphy, MD, professor and vice chair of medical imaging at the University of Toronto.