The AI module is intended to support physicians by evaluating bronchoscopic lung forceps biopsies on-site.
RT’s Three Key Takeaways:
- FDA Breakthrough Status: The FDA has granted Breakthrough Device Designation to Invenio Imaging’s NIO Lung Cancer Reveal, an AI tool designed to assist with real-time evaluation of bronchoscopic lung biopsy samples for cancer indicators.
- Assisting Limited ROSE Access: The NIO Lung Cancer Reveal aims to supplement rapid-on-site evaluation (ROSE) for lung biopsies, which is often unavailable during procedures, helping ensure adequate tissue sampling for biomarker and treatment determination.
- Not a Standalone Diagnostic: While the AI module detects suspicious cell/tissue morphology, it is not intended to serve as the primary diagnostic tool; physicians are advised to integrate its results with other clinical factors when making a diagnosis.
Invenio Imaging, an intraoperative fresh tissue imaging and artificial intelligence (AI) company, announced that the US 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, according to a release from Invenio Imaging.
Lung cancer is the leading cause of cancer-related deaths in the United States. Despite major advances in minimally invasive bronchoscopic lung biopsy technology, obtaining adequate tissue for biomarker and treatment determination remains a challenge.
Assisting Limited ROSE Access
For this reason, bronchoscopy guidelines recommend rapid-on-site tissue evaluation (ROSE) to determine if adequate tissue sample has been obtained. Despite its benefits, ROSE is often not available at the time of the procedure, and, in such a setting, NIO Lung Cancer Reveal image analysis module is intended to assist physicians in the evaluation of bronchoscopic lung forceps biopsies.
“We are excited by the FDA’s decision to grant breakthrough device designation for NIO Lung Cancer Reveal,” says Steve Pastore, MD, vice president of clinical affairs for Invenio Imaging, in a release. “This underscores the need to expand access to rapid on-site evaluation of bronchoscopic lung forceps biopsies using AI.”
The Breakthrough Devices Program is a voluntary program by the US FDA for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and premarket review.
Photo caption: NIO Laser Imaging System with NIO Lung Cancer Reveal image analysis module.
Photo credit: Invenio Imaging
