San Jose firm Invenio Imaging finished enrollment in ON-SITE, a U.S. pivotal study of NIO Lung Cancer Reveal, an AI module that flags cancer-suspicious morphology on fresh bronchoscopic biopsies imaged with its NIO system. The multicenter effort enrolled 1,006 patients across seven centers, with 32 physicians collecting more than 3,250 specimens by four biopsy techniques. The tool already holds FDA Breakthrough Device Designation; Invenio will analyze validation data for a regulatory submission. Why it matters: large prospective datasets remain rare for intraoperative AI pathology. Caveat: enrollment is not efficacy, and the product remains investigational in the United States.