DeepSight Technology announced it received FDA 510(k) clearance for its NeedleVue LC1 ultrasound system.
The company said clearance marks an important step forward in the development of its NeedleVue and OnPoint technologies. These work in tandem with the NeedleVue LC1 ultrasound system to transform image-guided procedures.
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DeepSight says NeedleVue can go beyond traditional imaging by combining high-resolution ultrasound with intelligent instrument tracking. This enables clinicians to pinpoint targets, navigate complex anatomy and perform interventions with sub-millimeter accuracy.
The company says its platform could apply to biopsies, tumor ablation, targeted drug delivery, vascular access and structural heart. It could also apply to spinal therapies, neuromodulation, minimally invasive surgery and robotic procedures. The therapy could reduce risk, radiation exposure and recovery time for patients worldwide.
Potential applications, among others, include abdominal biopsies, NeedleVue for ablation and structural heart repair.
“This is a foundational milestone in our mission to deliver crystal clear, sub millimeter level guidance inside the body. We have developed the next generation sensor technology for enhancing ultrasound where it what matters most—clear visualization, procedural efficiency, and user confidence,” said Nader Sadrzadeh CEO of DeepSight. “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.”
