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.
