FDA Clears Emerging Ultrasound Device for Interventional Procedures
Could the NeedleVue LC1 Ultrasound System reinvent real-time ultrasound-assisted needle guidance for interventional procedures?
The Food and Drug Administration (FDA) has granted 510(k) clearance for the NeedleVue LC1 Ultrasound System, which reportedly enhances the accuracy of minimally invasive device placement with advanced sensor technology.
The NeedleVue LC1 Ultrasound System enables real-time localization of the instrument tip during interventional procedures, according to DeepSight, the manufacturer of the ultrasound platform.
Through the use of advanced sensor technology, the newly FDA-cleared NeedleVue LC1 Ultrasound System enables real-time localization of the instrument tip during interventional procedures, according to DeepSight, the manufacturer of the ultrasound platform. (Image courtesy of DeepSight.)
Facilitating improved visualization and accuracy with device placement for ultrasound-guided procedures, DeepSight maintained the NeedleVue LC1 Ultrasound System enhances confident decision-making, even in challenging anatomy.
“(It is) absolutely useful to see the needle irrespective of the orientation with the transducer. The problem with today’s methods is the deeper you go with the needle, the less ability you have to see the needle tip. That makes deep biopsies exponentially harder. NeedleVue technology addresses this problem and could take share away from CT-guided biopsies,” noted James R. Duncan, M.D., Ph.D., a professor of radiology at the Mallinckrodt Institute of Radiology in St. Louis.
While traditional ultrasound-guidance for interventional procedures can be thwarted by complex calibration and reduced sensitivity, DeepSight emphasized the multidirectional design with the NeedleVue LC1 Ultrasound System allows high-fidelity tracking from a variety of orientations.
"(The FDA clearance) is a foundational milestone in our mission to deliver crystal clear, sub-millimeter level guidance inside the body," said Nader Sadrzadeh, the CEO of DeepSight. "We have developed the next generation sensor technology for enhancing ultrasound where it matters most — clear visualization, procedural efficiency, and user confidence.”
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