Invenio Imaging Completes Enrollment in AI Lung Cancer Biopsy Study

Invenio Imaging said in a press release that it has completed patient enrollment in the ON-SITE study, a U.S. pivotal study of NIO Lung Cancer Reveal. The AI image analysis module is being evaluated for rapid assessment of bronchoscopic lung biopsy specimens imaged with the NIO Imaging System.

The multicenter study enrolled 1,006 patients at seven medical centers, with participation from 32 physicians. It collected more than 3,250 fresh biopsy specimens across four bronchoscopic biopsy techniques.

The NIO Imaging System images fresh, unprocessed biopsy tissue without traditional freezing, sectioning, or staining. The specimen remains available for later pathology and molecular analysis. NIO Lung Cancer Reveal has received FDA Breakthrough Device Designation for its intended use to assist physicians in evaluating bronchoscopic lung forceps biopsies, and Invenio will analyze the ON-SITE validation data for a regulatory submission.