Medical device company Invenio Imaging has enrolled the first patients in a US trial of artificial intelligence (AI)-based NIO Laser Imaging System for lung cancer.
Invenio Imaging develops technologies that combine intraoperative fresh tissue imaging and AI to advance cancer care.
NIO Laser Imaging System is an image analysis module that enables rapid imaging of fresh tissue biopsies in the treatment room.
It is US Food and Drug Administration (FDA)-registered and CE-marked and has been utilised in over 10,000 procedures across neurosurgery, endoscopy, bronchoscopy, and urology.
The ON-SITE study, which integrates Stimulated Raman Histology with AI for swift lung cancer detection during bronchoscopy, is a multi-centre collaboration with Johnson & Johnson Enterprise Innovation, announced in January 2023.
The study will be conducted at several institutions, including The University of Texas MD Anderson Cancer Center, Corewell Health, Memorial Sloan Kettering Cancer Center, and the University of North Carolina at Chapel Hill.
Invenio Imaging co-founder and CEO Jay Trautman said: “Enrolling the first patient in the ON-SITE study is an important milestone for Invenio, as we aim to develop the first FDA-cleared AI to identify cell/tissue morphology suspicious for cancer in lung biopsies.
“Near real-time image analysis on the NIO Laser Imaging System completes the end-to-end solution for streamlined intraoperative histology.”
According to Invenio Imaging, sample preparation with the NIO Laser Imaging System is streamlined, as it does not require staining or sectioning and can be easily handled by existing operating room staff.
Additionally, NIO Slides are designed to enable sample retrieval for further analysis. The images produced by the system are digital and can be shared in near real-time for lung cancer management.
The ON-SITE study is focused on developing and validating an AI-based image analysis module for the NIO Laser Imaging System.
The module aims to assist physicians in detecting cancer in bronchoscopic lung biopsies, particularly in scenarios where Rapid On-Site Evaluation (ROSE) is not available for the sample type.
Invenio Imaging’s initial AI product, the NIO Glioma Reveal, received the CE mark in May 2022 and is now available for clinical use across Europe.
