Invenio Imaging Receives FDA Breakthrough Device Designation for AI-based Image Analysis Module to Assist Physicians in the Evaluation of Bronchoscopic Lung Biopsies

SANTA CLARA , Calif. , Oct. 30, 2024 /PRNewswire/ -- Invenio Imaging, a leader in intraoperative fresh tissue imaging and artificial intelligence (AI), announced today that the U.

S Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the NIO ® Lung Cancer Reveal image analysis module that is intended to assist physicians in the evaluation of bronchoscopic lung forceps biopsies. The NIO ® Lung Cancer Reveal detects cell/tissue morphology suspicious for cancer in images acquired with the NIO ® Laser 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 is the first device of its kind to receive Breakthrough Device Designation from the FDA..