DeepSight Technology has received 510(k) clearance from the US Food and Drug Administration (FDA) for its NeedleVue LC1 Ultrasound System.
NeedleVue is a stand-alone system designed to deliver ultrasound imaging and supports advanced NeedleVue and OnPoint guidance capabilities.
It is a non-electrical technology that measures as small as 50µm and allows integration into various medical instruments.
The technology provides trajectory guidance, real-time tracking, and an anatomic ultrasound view from the tip of almost any instrument.
Building on its foundational sensor technology, NeedleVue offers an advanced ultrasound solution.
The NeedleVue LC1 Ultrasound System is said to address several clinical challenges, including operating near critical structures.
It mitigates the need for precise targeting and controlled movements, complex hand-eye coordination.
Also, the device addresses limitations with conventional ultrasound systems, such as poor needle visibility in tissue, unreliable instrument tracking, and limited accuracy.
Other features include being impervious to magnetic fields, automatically self-calibrating, and enabling a free-hand workflow.
It can withstand extreme temperatures, operates within an ablation cloud and ultrasound contrast media, and enables precise localised temperature and pressure sensing.
The FDA approval is expected to enhance the medical device company’s NeedleVue and OnPoint technologies, designed to improve image-guided procedures.
DeepSight CEO Nader Sadrzadeh said: “This is a foundational milestone in our mission to deliver crystal clear, sub-millimetre level guidance inside the body.”
“We have developed the next generation sensor technology for enhancing ultrasound, where it matters most-clear visualisation, procedural efficiency, and user confidence.
“We’re just getting started and look forward to building on this achievement as we expand our clinical and commercial momentum in the months ahead.”
