The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Invenio for its image analysis module that is designed to assist physicians in evaluating bronchoscopic lung biopsies.
Invenio's NIO Lung Cancer Reveal uses artificial intelligence (AI)-based image analysis to detect cell and tissue morphology that is suspicious for cancer in images acquired with the NIO Laser Imaging System from fresh, unprocessed biopsy specimens. In a statement, the Santa Clara, CA-based Invenio noted that NIO Lung Cancer Reveal's output should be used by physicians in combination with other clinical information for diagnosis and decision-making, not for primary diagnosis.
Obtaining sufficient tissue for evaluation during bronchoscopic lung biopsy continues to be challenging, despite technological advances. While bronchoscopy guidelines recommend rapid onsite tissue evaluation (ROSE) to determine if adequate tissue was obtained, ROSE may not always be available. The NIO module is designed to assist physicians in assessing bronchoscopic lung biopsies when ROSE is not available.
The firm added that NIO Lung Cancer Reveal is the first device of its kind to receive FDA breakthrough device designation. Invenio's first AI-based module, the NIO Glioma Reveal, received the CE Mark in May 2022 and is available for clinical use in the EU.
