Invenio Imaging Completes Enrollment for AI Lung Cancer Detection Study
Invenio Imaging has announced the completion of patient enrollment for its ON-SITE study. The study evaluates AI-based image analysis software for the detection of lung cancer.
Invenio Imaging announced the conclusion of patient enrollment for its ON-SITE study, a U.S. pivotal trial. The study is designed to evaluate the NIO® Lung Cancer Reveal software, which uses artificial intelligence to analyze images of fresh tissue samples for lung cancer detection.
This U.S. pivotal study is a key step for the company as it seeks regulatory clearance from the U.S. Food and Drug Administration (FDA). The goal is to gather sufficient clinical data to support the validation of the NIO system.
The technology utilizes AI to analyze tissue sample imagery, aiming to improve diagnostic accuracy and potentially expedite the cancer detection process within pathology laboratories. The software identifies characteristics indicative of cancerous cells.
Invenio Imaging has not yet released specific timelines for the study's completion or the publication of its findings. The outcomes of the ON-SITE study will be critical for the company's future commercialization efforts in the United States.