DeepSight Secures FDA Clearance for NeedleVue™ LC1 Ultrasound System, Advancing Precision in Image-Guided Procedures
DeepSight Technology, an innovator in medical imaging, has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its NeedleVue™ LC1 Ultrasound System, a platform designed to enhance clarity and accuracy in image-guided procedures.
The approval represents a significant milestone in DeepSight’s development of its NeedleVue™ and OnPoint™technologies, which will operate in tandem with the LC1 system to deliver sharper visualization and greater confidence for clinicians. The company believes this breakthrough positions its technology to redefine standards in procedural ultrasound.
“This is a foundational milestone in our mission to deliver crystal clear, sub millimeter level guidance inside the body,”said Nader Sadrzadeh, 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. 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.”
The NeedleVue™ LC1 is designed to support procedures that rely heavily on precise ultrasound imaging for guidance, such as targeted biopsies, injections, and other minimally invasive interventions. By providing sub-millimeter resolutionand improved real-time visualization, the system is expected to help clinicians navigate instruments with greater accuracy, reduce complications, and improve overall workflow efficiency.
The LC1 system also represents a platform for the integration of DeepSight’s proprietary imaging technologies. NeedleVue™ technology enhances the visualization of needles and other instruments during procedures, while OnPoint™ focuses on streamlining workflow and delivering sharper, high-contrast imaging. Together, these innovations aim to provide physicians with the clarity needed to make confident clinical decisions and carry out delicate interventions with precision.
FDA clearance for the LC1 system is a critical step as DeepSight pursues both clinical adoption and commercial expansion. By targeting procedural ultrasound—a segment of the imaging market where precision is critical but existing tools often have limitations—the company is positioning itself as a leader in next-generation imaging solutions.
Looking ahead, DeepSight plans to build on this regulatory milestone with additional product integrations and broader market entry, leveraging the LC1 system as a launch point for future innovation.
The company notes that improved procedural ultrasound not only benefits clinicians but also patients, who stand to gain from safer, more efficient procedures with reduced risk of complications and improved diagnostic outcomes.
With the LC1’s clearance, DeepSight is now prepared to accelerate both clinical partnerships and commercial deployments, reinforcing its vision of transforming ultrasound into a more powerful tool for real-time, image-guided care.