Leadoptik has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance to its Last Inch Assessment (LIA) system, a platform that uses silicon photonics imaging technology and advanced software to improve the accuracy of lung biopsy procedures. The clearance covers the system’s consumable biopsy tool, imaging console and software.

Lung cancer remains the leading cause of cancer-related deaths globally, accounting for approximately 1.8 million deaths each year, more than the next three cancers combined. Early and accurate diagnosis is critical to improving outcomes, with early detection shown to increase five-year survival rates by up to 94 times. Central to early diagnosis is the ability to obtain precise, high-quality biopsy samples.

The company’s LIA system aims to address this challenge by transforming lung biopsy into a digital, tissue-intelligence workflow. The system integrates proprietary silicon metamaterials for depth imaging directly into standard biopsy tools, enabling real-time optical insight at the point of care. According to the company, the technology delivers up to 50 times higher imaging resolution than existing approaches.

Dr. George Cheng, said, “The LIA system represents the missing link in the bronchoscopy workflow. For the first time, high-resolution depth imaging is integrated directly into the biopsy tool, allowing physicians to see and characterise tissue from within. Existing workflows rely on external imaging or post-procedure validation, which add complexity and delay. Leadoptik addresses these limitations in a single, streamlined solution.”

While advances in robotic and navigational bronchoscopy have significantly improved physicians’ ability to reach pulmonary nodules, diagnostic success is not always guaranteed. The final step confirming that the biopsy tool has accurately sampled the target tissue has remained a key limitation in current workflows.

Dr. Ali Sadoughi highlighted the clinical significance of the technology, noting that proximity to a lung nodule alone is insufficient. “Confirming that the needle has sampled the correct tissue is the critical missing step. Leadoptik’s technology has the potential to improve confidence at the point of biopsy and close a long-standing gap in the procedure,” he said, adding that he will serve as a pilot site during the limited launch phase.

Reza Khorasaninejad, CEO and Co-Founder of Leadoptik, added, “Our preclinical data supporting this FDA clearance are exceptionally encouraging, demonstrating biopsy accuracy exceeding 95 percent. As we prepare the system for hospital deployment, our focus is on empowering physicians with real-time insight, particularly in borderline cases where imaging interpretation becomes the deciding factor. These advancements have the potential to accelerate diagnosis, improve treatment decisions, and meaningfully impact patient care.”

With FDA clearance secured, Leadopik plans to advance its roadmap toward AI-driven tissue interpretation, converting imaging data into immediate, actionable insights during interventional procedures.