LEADOPTIK Advances Lung Biopsy Care with First-in-Human LIA™ Procedure

LEADOPTIK, Inc., has announced the first-in-human clinical use of its FDA-cleared Last Inch Assessment™ (LIA) System at University of Chicago Medical Center. 

This follows the recent FDA 510(k) clearance of the device and marks an important step in validating its potential to improve diagnostic accuracy during lung biopsy procedures.

The LIA™ System uses integrated optical imaging to provide real-time, depth-resolved information at the point of tissue sampling. 

It is designed to help clinicians confirm that biopsy tissue is collected from the intended target, addressing a long-standing challenge in lung cancer diagnosis. 

In early cases, the system successfully differentiated nodules from healthy tissue, providing immediate confirmation during the procedure.

The device integrates seamlessly into existing biopsy workflows, supporting both physician confidence and patient care. 

Insights from these initial cases will inform future clinical studies and the ongoing development of advanced software and AI-based tissue characterisation tools.

Lung cancer remains the leading cause of cancer-related deaths worldwide, and while advances in navigational and robotic bronchoscopy have improved access to nodules, confirming accurate tissue sampling remains a critical unmet need. 

The LIA™ System aims to address this “last inch,” improving precision and diagnostic confidence for patients undergoing lung biopsy.