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

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Oct 30, 2024, 03:00 ET

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.

NIO Laser Imaging System with NIO Lung Cancer Reveal image analysis module.

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. 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," said Steve Pastore, MD, VP of Clinical Affairs for Invenio Imaging. "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 U.S. 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. Breakthrough Devices must meet the FDA's rigorous standards for device safety and effectiveness in order to be authorized for marketing. The Breakthrough Devices Program reflects the FDA's commitment to device innovation and protecting the public health. Granting of a Breakthrough Device Designation does not guarantee that the application will ultimately be approved.

About Invenio Imaging Inc.

Invenio Imaging is an emerging, privately held medical device company based in Santa Clara (CA) dedicated to advancing the care of cancer patients by combining intraoperative fresh tissue imaging and artificial intelligence. The NIO^® Laser Imaging System is FDA-registered and CE-marked and has been used in over 10,000 procedures across neurosurgery, bronchoscopy, urology, and endoscopy. Invenio Imaging's first AI product, the NIO^® Glioma Reveal, has received CE mark and is available for clinical use in Europe. Invenio received a Medical Design Excellence Award and was selected for the Rosenman Innovator and MedTech Innovator cohorts.

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SOURCE Invenio Imaging