FDA Clears LEADOPTIK's LIA System for Higher-Accuracy Lung Biopsy

The United States (US) Food and Drug Administration (FDA) has granted 510(k) clearance to LEADOPTIK’s Last Inch Assessment™ (LIA) system, a first-of-its-kind system designed to improve the accuracy of lung biopsy procedures.1

"The LIA system represents the missing link in the bronchoscopy workflow," George Cheng, MD, UC San Diego School of Medicine, a member of LEADOPTIK’s Clinical Advisory Board, said in a statement.1 "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 LIA system uses proprietary silicon metamaterials for depth imaging directly into standard biopsy tools. According to LEADOPTIK, the system offers 50x better imaging resolution than current technologies.

"The 'last inch' is where the path to timely intervention is ultimately determined," said Ali Sadoughi, MD, Albert Einstein College of Medicine, and another member of LEADOPTIK’s Clinical Advisory Board.1 "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."

"Our preclinical data supporting this FDA clearance are exceptionally encouraging, demonstrating biopsy accuracy exceeding 95%," 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."

Lung cancer remains the leading cause of cancer-related death globally, responsible for nearly 1.8 million deaths annually, more than the next leading 2 combined (colorectal and liver cancer).2 Lung cancer outcomes hinge on timely diagnosis, a hurdle that scientists, clinicians, and health systems are becoming increasingly equipped to overcome.

“Despite all the evidence we have, too many patients fall through the cracks,” she said. “We know we can reduce lung cancer mortality by 20 to 25% with screening. We just have to get them screened,” Mary Pasquinelli, DNP, who directs the lung screening program at UI Health in Chicago, previously told HCPLive.

Pasquinelli and her team focus on low-dose CT (LDCT) screening for high-risk patients, which has long been shown to reduce mortality.3 At her institution, a hybrid screening model that combines centralized coordination with primary care integration has substantially helped improve screening rates. Pasquinelli’s team proactively monitors LDCT orders, reaches out directly to patients, and ensures adherence with follow-up scans and consultations.

Her program includes comprehensive shared decision-making visits, often the first point of education for patients facing lung cancer risk, as well as smoking cessation support.

“Many of my patients are anxious. They feel shame about smoking, or they fear what we’ll find,” she said. “But I sit down and explain what pulmonary nodules are, what the scan does and doesn’t show, and that most findings are benign. When they understand that, they almost always go forward.”

References

1. LEADOPTIK Announces FDA Clearance of the LIA™ for Lung Biopsy Procedures. News release. LEADOPTIK. January 15, 2026. Accessed January 16, 2026. https://www.prnewswire.com/news-releases/leadoptik-announces-fda-clearance-of-the-lia-for-lung-biopsy-procedures-302662402.html

2. World Health Organization. Cancer Fact Sheet. World Health Organization. Updated February 2022. Accessed January 16, 2026. https://www.who.int/news-room/fact-sheets/detail/cancer

3. National Lung Screening Trial Research Team. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011;365(5):395–409. doi:10.1056/NEJMoa1102873