Workshops 2020. Robert Ochs, PhD, Deputy Director for Radiological Health, Office of In Vitro Diagnostics and Radiological Health (FDA), New Challenges in Regulating Artificial Intelligence in Radiological Imaging, Emerging Trends in Radiological AI Software - Exploring Benefits and Risks Nicholas Petrick, PhD, Deputy Director Division of Imaging, Diagnostics and Software Reliability, Office of Science and Engineering Laboratories (FDA), Pre- and Post-Market Evaluation of Autonomous AI/ML: Lessons Learned from Prior CAD Devices, Matthew Diamond, MD, PhD, Medical Officer, Digital Health, Center for Devices and Radiological Health (FDA), Proposed Regulatory Framework for Modifications to Artificial Intelligence/ Machine Learning (AI/ML)- Based Software as a Medical Device (SaMD), Peter Chang, MD, Assistant Professor-in-Residence, Department of Radiological Sciences, Co-Director, Center for Artificial Intelligence in Diagnostic Medicine (CAIDM), University of California, Irvine, Evolving Paradigms of Radiology AI Software - Current and Future Trends, Laura P Coombs, PhD, VP, Data Science and Informatics, American College of Radiology and Keith Dreyer DO, PhD, FACR, FSIIM, Chief Data Science Officer, Partners Healthcare, Chief Science Officer, ACR Data Science Institute, The AI Lifecycle: Evaluating and Monitoring AI Algorithms, Robert Lindsey, PhD, Co-Founder & Chief Science Officer, Imagen Technologies, Post-Market Surveillance Methods for AI in Radiology, Evaluation of AI Software for Radiological Applications- Discussion Panel While historically the information provided by these algorithms has augmented the tasks performed by radiologists, software developments now can enable the devices to perform certain tasks autonomously. Center for Devices and Radiological Health Senior Director, Systems Engineering and QA, Hologic, Bibb Allen, MD, FACR, Chief Medical Officer, American College of Radiology Data Science Institute, David Kent, MD, Professor of Medicine, Neurology and Clinical and Translational Science; Director, Predictive Analytics and Comparative Effectiveness (PACE) Center, ICRHPS; Attending Physician, Tufts Medical Center, Constance Lehman, MD, PhD, FACR, Harvard Medical School, Massachusetts General Hospital, Gary Levine MD, Medical Officer, Division of Radiological Health, FDA, Ronald M. Summers, MD, PhD, FSAR, FAIMBE, Imaging Biomarkers and Computer-aided Diagnosis Lab, Radiology and Imaging Sciences, NIH Clinical Center (NIH), Bakul Patel, MSEE, MBA, Division of Digital Health, FDA, Robert Ochs, PhD, Office of In Vitro Diagnostics and Radiological Health, FDA, Richard Frank MD, PhD, Chief Medical Officer, Siemens Healthineers, Maryellen L. Giger, PhD, Professor, Department of Radiology, University of Chicago and Advisor, Qlarity Imaging, Arun Krishnan, PhD, Development Executive, AI Algorithms, IBM Watson Health Imaging, David B. Larson, MD, MBA, Associate Professor of Pediatric Radiology Vice Chair of Education and Clinical Operations Department of Radiology, Stanford University School of Medicine, Holger Roth, PhD, Sr. Moderator: Jessica Lamb, PhD, Assistant Director (Acting), Mammography, Ultrasound, and Imaging Software Team, Division of Radiological Health (FDA). if (document.registration.lastname.value == "") {window.alert("Please supply your last name. The workshop was originally a meeting for FDA statisticians that later expanded to include all statisticians interested in statistical practices for all areas regulated by the FDA. Despite the pandemic the 53 novel drugs approved in 2020 bested 2019’s 48 approvals but fell short of the 59 approved in 2018. Each year the conference lasts two days with invited sessions co-chaired by statisticians from industry, academia, and FDA. Moderator: Shahram Vaezy, PhD, Biomedical Engineer, Division of Radiological Health (FDA). Join us for this four-part Webinar Series on Sept. 2, Sept. 3, Sep. 9, and Sept. 10. [CDATA[// >. Advances in AI technology are leading to an expanding role for AI throughout the diagnostic clinical workflow. The FDA's Center for Devices and Radiological Health (CDRH) announced on January 16, 2020, that it will host a public workshop on March 5 to discuss virtual and augmented reality in medicine. CADe and CADx software analyze radiological images to suggest clinically relevant findings and aid diagnostic decisions. return true; } Workshops & Conferences (Medical Devices), Recalls, Market Withdrawals and Safety Alerts, Workshops & Conferences (Medical Devices), 2020 Medical Device Meetings and Workshops, 2019 Medical Device Meetings and Workshops, 2018 Medical Device Meetings and Workshops, 2017 Medical Device Meetings and Workshops, Medical Device Webinars and Stakeholder Calls, Public Workshop - Evolving Role of Artificial Intelligence in Radiological Imaging - 02/25/2020 - 02/26/2020, Artificial Intelligence in Breast Cancer Screening: Regulatory and Clinical Considerations, Scientific, Clinical & Regulatory Challenges for Radiological AI Software, AI in Nuclear-Medicine Imaging: Opportunities and Risks, The Role of Medical Physics in Artificial Intelligence in Medical Imaging, The Importance of Data Quality and True Noise, AI in Medical Imaging and Decision Support: The Perspective of the RSNA Quantitative Imaging Biomarkers Alliance (QIBA®), Deployment of AI in Hospitals: Considerations Beyond AI Models, Autonomous AI and Ethics: lessons from real world implementation: Role of Physicians, Explainable AI and Regulation in Medical Devices, AI in Pediatric Radiology: Special Considerations, Ethics, and Explainability, AI software for image enhancement and better acquisition, AI-enabled imaging acquisition, image transformation, and dose reduction, How Investors Can Encourage Startups to Work Constructively with the FDA, NCI Funding Opportunities for Early, Mid, Advanced and Translational Stage AI Imaging Developments, Instructions for Submitting Comments - Evolving Role of Artificial Intelligence in Radiological Imaging, Clinical Insights on Autonomous AI Implementation: A Radiologist's Perspective, AI in Medical Imaging and Decision Support: The Perspective of the RSNA Quantitative Imaging Biomarkers Alliance, Deployment of AI in Hospitals: Considerations Beyond AI Models, Lisa M. Baumhardt, IBM Watson Health Imaging, Nikos Gkanatsios, PhD. NIH VideoCasting. Moderator: Robert Sauer, Deputy Director, Division of Program Operations and Management (FDA), Scientific, Clinical & Regulatory Challenges for Radiological AI Software, R. Chad McClennan, MBA, President & CEO, koios, AI in Dental Radiography, E. Gültürk, Head of Quality & Regulatory, videahealth, AI-Assisted Autonomous Imaging: Brain MR, G. Srinivasan, MediYantri, AI in Nuclear-Medicine Imaging: Opportunities and Risks, A. K. Jha, Assistant Professor of Biomedical Engineering, Washington University, Will AI Make a Better Doctor? The following public workshop Agenda is current as of 2/28/2020 and subject to change. S. Wu, Associate Professor, Director, Intelligent Computing for Clinical Imaging (ICCI) Lab, Dept. One Bethesda Metro Center, Bethesda, MD 20814 Early applications of AI in radiological imaging include computer aided-detection and diagnosis software (CADe and CADx). Radiological applications of AI-based technologies are numerous and expanding. T: (301) 657-1234, F: (301) 657-6453, Marriott Suites Bethesda Home » Workshops 2020. Make sure to register early. The potential for independent action by these devices to bypass human clinical review is an important factor in their benefit-risk profile, and it heightens expectations for the safety and effectiveness of these devices. J. Weiner, Boca Raton Regional Hospital, The Role of Medical Physics in Artificial Intelligence in Medical Imaging, C. H. McCollough, Professor of Medical Physics and Biomedical Engineering, Mayo Clinic, NCI Image Repositories for Imaging AI, K. Farahani, National Cancer Institute, The Importance of Data Quality and True Noise, P. Kinahan, Vice Chair of Radiology, University of Washington, Chair AAPM Research Committee, AAPM Metrology and Standards Subcommittee, AI in Medical Imaging and Decision Support: The Perspective of the RSNA Quantitative Imaging Biomarkers Alliance (QIBA®), T. J. Registrants will receive confirmation when requests for participation have been accepted. Please call (717) 814-9873 or visit http://www.afdo.org/grants/retailstandards for assistance with the Retail Program Standards Grant Program. T: (301) 718-0200, F: (301) 718-0679. CIT can broadcast your seminar, conference or meeting live to a world-wide audience over the Internet as a real-time streaming video. NIH Main Campus 66, Rm 3545. During online registration, you may indicate if you wish to present during a public comment session, and which topics you wish to address. [CDATA[> Eventbrite - FDA presents FDA Workshop for the Reproductive Tissue Industry - Tuesday, September 29, 2020 | Thursday, October 1, 2020 - Find event and ticket information. \nPlease make sure it's correct. FDA-AACR Workshop to Address Multiple Myeloma Clinical Trial Disparities. The ACR recognizes the myriad possible use cases for extended reality medical devices within diagnostic and interventional radiology. Presentations will discuss the impact of radiological AI software on standard of care, clinical benefit, and risk. Presentations will discuss individual and collaborative efforts to develop validation methods for imaging-related AI inside and outside the traditional medical imaging community. Artificial intelligence may be applied in imaging to provide guidance for the operator to acquire optimal images and signals. A. Patel, Chair, Department of Radiology, Medical Director – Artificial Intelligence, Vice Chair, Imaging Informatics, Medical Director – 3D Laboratory, Geisinger, AI in Pediatric Radiology: Special Considerations, Ethics, and Explainability, A. Annapragada, Professor and Director of Basic Research in Radiology, The E.B.Singleton Department of Pediatric Radiology, Texas Children’s Hospital and Baylor College of Medicine, Applications of AI to Ultrasonography, H. Sagreiya, Assistant Professor of Radiology, University of Pennsylvania, AI software for image enhancement and better acquisition, E. Gong, Subtle Medical, AI-enabled imaging acquisition, image transformation, and dose reduction, G. Zaharchuk, Professor of Radiology, Stanford University, Build Trustworthy Medical Imaging AI. Participants in this moderated discussion panel include: Public Presentations If you need special accommodations due to a disability, please contact Susan Monahan at 301-796-5661, at susan.monahan@fda.hhs.gov at least 7 days in advance of the meeting. Moderator: Brian Garra, MD, Physician, Division of Imaging, Diagnostics, and Software Reliability (FDA), Helen Feltovich, MD MS, Attending Physician, Intermountain Healthcare, and Associate Research Scientist, Medical Physics, University of Wisconsin, Madison, What's Real About Artificial Intelligence: A Clinician's Perspective, Jean Lea Spitz, MPH, CAE, RDMS, Executive Director, Perinatal Quality Foundation, Artificial Intelligence (AI) and the Art of Sonography, Joshua Basile, Founder, Determined2Heal & SPINALpedia; Mike Washburn, Chief Engineer, GE Healthcare - Ultrasound, AI-guided ultrasound image acquisition; GE perspective, AI-Guided Image Acquisition: Clinical and Patient Perspectives Validation of device performance with respect to the intended use is critical to assess safety and effectiveness. Workshops 2020. March 9, 2020 . Moderator and Presenter: Jennifer Segui, Lead Reviewer, Division of Radiological Health (FDA), Perspectives on the AI-Automated Radiology Workflow, Day 2 Organizing Committee: Shahram Vaezy PhD, Marjan Nabili PhD, Tracy Gray, Jennifer Segui (FDA), Welcome Day 2 The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, POUF! 8120 Wisconsin Avenue, Bethesda, MD 20814 Workshops, Public Workshop - Evolving Role of Artificial Intelligence in Radiological Imaging, An official website of the United States government, : if ((document.registration.email.value != "") && (document.registration.email2.value != document.registration.email.value)) {window.alert("Your email address does not match the validation line you typed. Novel drug approvals continued at a brisk clip, averaging over one per week in 2020. [CDATA[// >