Invenio Imaging Receives FDA Breakthrough Designation for AI-Powered Lung Biopsy Analysis Module

Invenio Imaging has announced that the U.S. FDA has granted Breakthrough Device Designation for its NIO® Lung Cancer Reveal image analysis module.

This innovative technology is designed to help doctors evaluate bronchoscopic lung forceps biopsies. The NIO® Lung Cancer Reveal identifies cell and tissue morphology that may be suspicious for cancer in images taken with the NIO® Laser Imaging System from fresh, unprocessed biopsy samples.

It is important to note that the device’s results should not be used as the primary diagnosis, and doctors should consider other clinical factors when making decisions.

 Although advances have been made in minimally invasive bronchoscopic lung biopsy technology, obtaining sufficient tissue for biomarker and treatment determination is still a significant challenge.

For this reason, bronchoscopy guidelines recommend rapid on-site tissue evaluation (ROSE) to confirm that an adequate tissue sample has been collected.

However, ROSE is often unavailable at the time of the procedure, making the NIO® Lung Cancer Reveal an essential tool in assisting doctors with biopsy evaluation.

The FDA’s Breakthrough Devices Program is a voluntary initiative designed to speed up the development, assessment, and approval process for devices that offer more effective treatments or diagnoses for life-threatening or severely debilitating conditions.

Source: https://www.prnewswire.com/news-releases/invenio-imaging-receives-fda-breakthrough-device-designation-for-ai-based-image-analysis-module-to-assist-physicians-in-the-evaluation-of-bronchoscopic-lung-biopsies-302290901.html