Invenio Imaging is bringing fresh tissue imaging into the bronchoscopy suite as a next generation approach to rapid on-site evaluation (ROSE) of lung biopsy specimens.
The NIO® Imaging System rapidly images fresh, unprocessed biopsy tissue without traditional freezing, sectioning, or staining, while allow retrieving for the specimen for downstream pathology and molecular analysis.
To build on this imaging platform, Invenio recently completed patient enrollment in ON-SITE, a prospective, multicenter U.S. pivotal study evaluating NIO® Lung Cancer Reveal, an AI-based image analysis module for the rapid assessment of bronchoscopic lung biopsy specimens imaged with the NIO® Imaging System. The study enrolled 1,006 patients across seven medical centers and collected more than 3,250 fresh biopsy specimens.
Watch the video to learn more about Invenio’s technology and application in interventional pulmonology, and visit booth #28 at AABIP 2026 to meet the team.
The NIO® Imaging System is FDA-registered and CE-marked. NIO® Lung Cancer Reveal received FDA Breakthrough Device Designation for its intended use to assist physicians in the evaluation of bronchoscopic lung forceps biopsies. NIO® Lung Cancer Reveal detects cell/tissue morphology suspicious for cancer in images acquired with the NIO® Imaging System from fresh/unprocessed biopsy specimens. Its output should not be used as the primary diagnosis, and physicians should consider all other clinical factors when making a clinical decision. NIO® Lung Cancer Reveal remains investigational in the United States and has not been cleared or approved for clinical use.