WEB Invenio Imaging Announces First Patients Enrolled in US Pivotal Study of AI-Based Image Analysis Module
WEB Invenio Imaging Announced Start of Patient Enrollment in a US Pivotal Study of Its AI-Based Image Analysis Module
WEB Invenio Imaging, a leader in intraoperative fresh tissue imaging and artificial intelligence (AI), announced that it has begun enrolling patients in a pivotal study of its AI-based image analysis module for the NIO Laser. The ON-SITE study aims to develop and validate an AI-based image analysis module for the NIO system that is designed to assist surgeons in identifying cancerous tissue during surgery.
About the ON-SITE Study
The ON-SITE study is a prospective, multicenter, single-arm study that will enroll approximately 500 patients at up to 15 sites in the United States. The study will evaluate the safety and effectiveness of the AI-based image analysis module in assisting surgeons in identifying cancerous tissue during surgery. The primary endpoint of the study is the positive predictive value (PPV) of the AI-based image analysis module for identifying cancerous tissue.
About WEB Invenio Imaging
WEB Invenio Imaging is a privately held medical device company that develops and markets innovative imaging technologies for use in surgery. The company's NIO Laser is a minimally invasive laser-based imaging system that allows surgeons to visualize fresh tissue in real-time during surgery. The company's AI-based image analysis module is designed to assist surgeons in identifying cancerous tissue during surgery, which can help to improve surgical outcomes.
Komentar