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.

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