LEADOPTIK Announces FDA Clearance of the LIA™ for Lung Biopsy Procedures

SAN JOSE, Calif., Jan. 15, 2026 /PRNewswire/ — LEADOPTIK, Inc. today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Last Inch Assessment™ (LIA) system, the world’s first system to use silicon photonics imaging technology and software designed to improve the accuracy of lung biopsy procedures.

Lung cancer remains the leading cause of cancer-related death worldwide, claiming approximately 1.8 million lives each year, more than the next three cancers combined. Early diagnosis is critical to survival, increasing five-year survival rates by up to 94x, and it heavily depends on obtaining precise, high-quality biopsies.

LEADOPTIK’s LIA system addresses this gap by transforming lung biopsy into a digital, tissue-intelligence workflow. The system integrates proprietary silicon metamaterials for depth imaging directly into standard biopsy tools, delivering real-time optical insight at the point of care with 50× better imaging resolution than current technologies.

In recent years, robotic and navigational bronchoscopy systems have made significant advances in reaching pulmonary nodules. However, successful navigation does not guarantee diagnostic success. The final step, which ensures that the tool actually samples the target tissue, remains the weakest link.

“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. Today’s workflows rely on external imaging or post-procedure validation, both of which add complexity and delay. LEADOPTIK addresses these limitations in a single, streamlined solution. I’ve worked with the team from the early days of development and am very excited to use the LIA system as part of the limited launch.”

“The ‘last inch’ is where the path to timely intervention is ultimately determined,” said Dr. Ali Sadoughi. “Being close to a lung nodule is not enough, confirming that the needle has sampled the correct tissue is the critical missing step. LEADOPTIK’s technology has the potential to fundamentally improve confidence at the point of biopsy and close a long-standing gap in the procedure. I’m excited to be involved in the limited launch and to serve as a pilot site.”

With FDA clearance for the consumable biopsy tool, imaging console, and software, LEADOPTIK’s roadmap now advances toward AI-driven tissue interpretation, transforming imaging data into immediate, actionable insights during interventional procedures.

“Our preclinical data supporting this FDA clearance are exceptionally encouraging, demonstrating biopsy accuracy exceeding 95%,” said Reza Khorasaninejad, CEO and Co-Founder of LEADOPTIK. “We are in a uniquely strong position to address one of the most critical unmet needs in lung cancer diagnostics. As we prepare the system for hospital deployment, our focus is on empowering physicians with real-time insight, especially in borderline cases where imaging interpretation becomes the deciding factor. These improvements could meaningfully change patient care, accelerate diagnosis, and improve treatment outcomes.”

About LEADOPTIK:

LEADOPTIK is a Silicon Valley–based company transforming biopsy into a digital tissue-intelligence workflow. By integrating proprietary depth-resolved imaging technology with emerging analytics, LEADOPTIK’s Last Inch Assessment™ (LIA) system bridges the gap between navigation and pathology, enabling more precise and informed decision-making in interventional pulmonology and beyond.

For more information, visit www.leadoptik.com.

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SOURCE LEADOPTIK