LEADOPTIK Receives FDA Clearance for LIA System in Lung Biopsy Procedures
California-based LEADOPTIK has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Last Inch Assessment (LIA) system, a lung biopsy platform that integrates imaging technology directly into biopsy tools. The clearance covers the consumable biopsy device, imaging console, and associated software, enabling clinical use in U.S. hospitals.
Lung cancer remains the leading cause of cancer-related mortality worldwide, with outcomes closely tied to early and accurate diagnosis. While recent advances in robotic and navigational bronchoscopy have improved access to pulmonary nodules, confirming that a biopsy tool has sampled the intended tissue continues to be a key procedural challenge. LEADOPTIK’s system is designed to address this final step by providing real-time insight at the point of tissue sampling.
The LIA system incorporates silicon photonics–based depth imaging into standard biopsy instruments, creating what the company describes as a digital workflow for lung biopsy. By delivering optical information from within the tissue, the platform aims to support more precise sampling decisions during procedures, rather than relying solely on external imaging or post-procedure validation.
“The LIA system represents the missing link in the bronchoscopy workflow,” said Dr. George Cheng. “For the first time, high-resolution depth imaging is integrated directly into the biopsy tool, allowing physicians to see and characterize tissue from within.” He noted that existing approaches often require additional imaging steps, which add time and complexity. Dr. Ali Sadoughi emphasized the importance of tissue confirmation at the point of biopsy, stating that proximity to a lung nodule alone does not ensure diagnostic success. “Confirming that the needle has sampled the correct tissue is the critical missing step,” he said, adding that the technology could improve procedural confidence during biopsy.
With FDA clearance in place, LEADOPTIK plans to advance its development roadmap toward AI-based tissue interpretation, building on imaging data generated during procedures. According to CEO and co-founder Reza Khorasaninejad, preclinical data supporting the clearance showed biopsy accuracy exceeding 95%, positioning the company to move toward initial hospital deployments and broader clinical evaluation.
