Invenio Imaging announced today that it has obtained the CE Mark for the NIO Laser Imaging System according to the In Vitro Diagnostic Directive (IVDD).
| SANTA CLARA, Calif., Sept. 28, 2021 /PRNewswire/ -- Invenio Imaging announced today that it has obtained the CE Mark for the NIO Laser Imaging System according to the In Vitro Diagnostic Directive (IVDD). This enables commercialization of this novel imaging system for intraoperative histology in the European market.
The NIO Laser Imaging System uses Stimulated Raman Histology to image fresh, unprocessed tissue specimens without sectioning or staining, enabling histologic evaluation without need for a laboratory. The sample is mounted in a custom, easy-to-use NIO Slide and can be retrieved for downstream analysis with traditional and advanced genomic methods. NIO images are natively digital and can be shared instantly for review by pathology using existing hospital IT infrastructure. This allows streamlining intraoperative pathology consultations, enabling surgeons to make accurate surgical decisions based on histology. “Getting the CE mark is the result of our continuing effort to design and manufacture safe and effective medical devices and represents a major regulatory milestone for Invenio that allows us to introduce our technology into the EU market,” said Reyhan Mutlu, Director of Quality at Invenio Imaging. “I would like to thank the entire R&D and quality teams for making this milestone possible.” “The NIO Laser Imaging System represents an outstanding technique revolutionizing fast and precise intraoperative diagnosis of brain tumors,” said Prof. Dr. Georg Widhalm, neurosurgeon at the University of Vienna. “NIO fits into our neurosurgical workflow as if it had always been there. Now we can test its potential for neurosurgical intraoperative decision making and real time quality control,” said Prof. Dr. Juergen Beck, Chair of Neurosurgery at the University of Freiburg. “The intraoperative diagnostic potential of the NIO Imaging System complements the surgeons’ tools in the OR and may turn out to be the missing piece of the puzzle that enables a more precise and efficient brain tumor surgery,” said Asst. Prof. Dr. Volker Neuschmelting, neurosurgeon at the University of Cologne. About Invenio Imaging Inc. Invenio Imaging, based in Santa Clara, CA has developed and manufactures the NIO Laser Imaging System. The NIO is designed to streamline intraoperative histology, reducing downtime in the OR and allowing examination of specimens from multiple sites in the surgical cavity. It has been used in over 1800 cases and is currently installed in sites across the United States. Invenio recently received a Medical Design Excellence Award and was selected to be a Rosenman Innovator. www.invenio-imaging.com Contact:
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