FDA Clears DeepSight’s NeedleVue LC1 Ultrasound System

DeepSight Technology has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NeedleVue LC1 Ultrasound System.

The clearance marks an important step forward in DeepSight’s development of its NeedleVue and OnPoint technologies that will work in tandem with the NeedleVue LC1 Ultrasound System for image-guided procedures. “This is a foundational milestone in our mission to deliver crystal clear, sub millimeter level guidance inside the body,” DeepSight CEO Nader Sadrzadeh said. “We have developed the next- generation sensor technology for enhancing ultrasound where it what matters most—clear visualization, 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.”

DeepSight’s NeedleVue technology aims to redefine ultrasound-guided procedures by delivering real-time, ultrasound-based localization of the instrument tip with unmatched accuracy. Designed to seamlessly integrate into standard clinical workflows, NeedleVue eliminates the need for radiation or electromagnetic tracking systems—offering a simpler and more intuitive solution. By providing precise tip visibility even in challenging anatomy, NeedleVue empowers clinicians to perform biopsies, ablations, and targeted therapies with greater confidence and control, ultimately improving procedural outcomes and patient outcomes.

Founded in 2019 by Nader Sadrzadeh, Lan Yang, and Anand Chandrasekher, DeepSight Technology is striving to revolutionize medical imaging through proprietary sensing technology. With offices in the San Francisco Bay Area and Clayton, Mo., DeepSight aims to extend the capabilities of ultrasound across diagnostic, therapeutic, surgical, and interventional applications.