Leadoptik announces FDA approval for lung biopsy procedures

21 Jan 2026

OCT-guided LIA device is "missing link in bronchoscopy workflow."

California's Leadoptik, developer of a miniaturized imaging platform for minimally invasive surgical procedures, has announced FDA 510(k) clearance for its Last Inch Assessment (LIA) technology, an imaging device targeted at lung biopsy procedures.

Lung cancer remains the leading cause of cancer-related death worldwide, claiming 1.8 million lives each year. Early diagnosis is critical to survival, and heavily depends on obtaining precise, high-quality biopsies.

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

Leadoptik intends its LIA system to address this issue by transforming lung biopsy into "a digital, tissue-intelligence workflow," according to the company.

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 2023 Leadoptik announced the raising of $5 mllion in seed funding to support development of an ultra-thin imaging probe much smaller than a conventional bronchoscope, capable of accessing the tiniest airways in the lung.

"By using proprietary optics made from dielectric metasurfaces, Leadoptik has shrunk the optical elements to a size comparable with that of human hair," commented the firm at the time, indicating that FDA approval for the device was the next goal on its list.

Critical unmet needs in lung cancer diagnosis

According to Leadoptik's FDA application, the LIA catheter is an OCT-guided biopsy needle designed for use with endobronchial lesions, peripheral lung nodules, and lung masses. The device collects real-time two-dimensional, cross-sectional depth images which are visualized for evaluation of human tissue microstructure on the LIA Console.

"The LIA system represents the missing link in the bronchoscopy workflow," said George Cheng, a member Leadoptik's clinical advisory board.

"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."

A key aspect for the company's "last inch" philosophy is the ability not only to get close to a lung nodule under observation but confirm that the biopsy needle has sampled the correct tissue. Achieving this means the LIA system has the potential to fundamentally improve confidence at the point of biopsy and close a long-standing gap in the procedure, noted the company.

With FDA clearance granted, 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 percent," said Reza Khorasaninejad, Leadoptik CEO and co-founder.

"We are in a uniquely strong position to address one of the most critical unmet needs in lung cancer diagnostics. These improvements could meaningfully change patient care, accelerate diagnosis, and improve treatment outcomes."