We announced today that the U.S Food and Drug Administration (FDA) has granted Breakthrough Device Designation for our NIO® Lung Cancer Reveal image analysis module. “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.” Granting of a Breakthrough Device Designation does not guarantee that the application will ultimately be approved.
Invenio Imaging
医疗设备制造业
Santa Clara，California 3,402 位关注者
Improving the care of cancer patients through rapid onsite tissue imaging and AI
关于我们
Invenio Imaging is a medical device start-up based in Santa Clara, CA dedicated to advancing the care of cancer patients by combining intraoperative histologic imaging with artificial intelligence. Our technology, the NIO® Laser Imaging System has been used in over 2500 cancer treatment procedures at major cancer centers both in the US and in Europe. In 2021 Invenio received a Medical Design Excellence Award, was selected to be a Rosenman Innovator and received CE Mark to commercialize in Europe.
- 网站
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http://invenio-imaging.com
Invenio Imaging的外部链接
- 所属行业
- 医疗设备制造业
- 规模
- 11-50 人
- 总部
- Santa Clara，California
- 类型
- 私人持股
- 创立
- 2012
- 领域
- neurosurgery、pathology、AI、laser、neuropathology、medical device、intraoperative imaging、medtech、cancer care、brain tumor、neuroscience、Artificial Intelligence、interventional pulmonolgy、Stimulated Raman Histology、glioma、pancreas、lung、prostate、arti和Surgical oncology
地点
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主要
获取路线
2310 Walsh Ave
US，California，Santa Clara，95051
Invenio Imaging员工
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John L Seamans
Medtech & Biotech VC Fund Manager | Startups | Biomedical Engineer | Board Member
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Jay Trautman
Medical Device, Therapeutic and Life Science R & D and Commercialization
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Florian Khalid
Revolutionizing rapid intraoperative tissue analysis
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Taren Truong Nguyen, MS
Global Vice President of Regulatory and Quality Affairs at Invenio Imaging Inc.
动态
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We announced today the first patients enrolled in the US pivotal study of AI-based image analysis module for lung cancer. “We aim to develop the first FDA-cleared AI to identify cell/tissue morphology suspicious for cancer in lung biopsies," said Jay Trautman, PhD, co-founder and CEO of Invenio Imaging.
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It was a pleasure to connect with the growing NIO Community during our 2nd Annual European User Meeting and learn about everyone's latest updates. Special thanks to Prof. Dr. Beck for initiating this year's meeting and Prof. Dr. Rohde for enabling the Lunch Symposium at the DGNC Annual Meeting.
A huge thank you to all the speakers who made our 2nd European NIO Symposium on Stimulated Raman Histology and Artificial Intelligence a success at the 75th Annual Meeting of the German Society of Neurosurgery Deutsche Gesellschaft für Neurochirurgie in Göttingen #DGNC2024! The room was packed with medical professionals eager to explore how Invenio Imaging's NIO Laser Imaging System can streamline intraoperative histology. #digitalpathology #artificialintelligence #fightcancer
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Thank you for joining us at the German Society for Neurosurgery Annual Meeting in Gottingen. See you again next year!
Don't miss your last chance to meet us in an incredible location at the 75th Annual Meeting of the German Society of Neurosurgery Deutsche Gesellschaft für Neurochirurgie (#DGNC) 2024 in Göttingen! Stop by our booth to meet the Invenio Imaging team and learn more about revolutionary ways to detect cancer with intraoperative tissue analysis and #artificialintelligence. #digitalpathology #NIOLaserImagingSystem #invenioimaging #fightcancer
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