Pascal Wettstein: FDA or MDR? Where should SMEs go for their AI SaMD

Daniel Hashimoto is an assistant Professor of Surgery at the Hospital of the University of Pennsylvania, USA. Dan has developed multiple computer vision algorithms for the analysis of surgical video, led international consensus on defining ground truth for the annotation of surgical video, and worked to define metrics to assess performance of AI algorithms on surgical tasks. His work has been published in the New England Journal of Medicine, Nature Biotechnology, Annals of Surgery, and other journals. He is editor of the textbook Artificial Intelligence in Surgery: Understanding the Role of AI in Surgical Practice. He is also heavily involved in MICCAI society with a focused attention to CLINICCAI.

Prof. Stephen Gilbert is a professor in Medical Device Regulatory Science at the Else Kröner Fresenius Center for Digital Health in TU Dresden, Germany. His research goal is to advance regulatory requirements, especially for software as a medical device and artificial intelligence in medical devices. Papers we discussed: Large language model AI chatbots require approval as medical devices Continuous Improvement of Digital Health Applications Linked to Real-World Performance Monitoring: Safe Moving Targets?

Prof. Nitika Pai is an Associate Professor in the Department of Medicine at the McGill University, Canada. Her global implementation research program in Canada, India and South Africa is primarily focused on point-of-care diagnostics for HIV and associated co-infections. Her research informs domestic and global policy on point-of-care diagnostics.

Prof. Swapnil Rane is a Pathologist by training, and currently a professor in Tata Memorial Center, Mumbai, India. He is instrumental in bringing forward the AI and digital pathology research from India, especially the ongoing project of Indian Image BioBank.

Dr. Ishita Barua leads AI in healthcare at Deloitte, with a focus on improving equity and outcomes in digital health. She is a medical doctor and PhD by training with expertise in application and clinical validation of AI in Medicine. Ishita has won numerous awards including Top 50 women in tech and top 30 women in Norway shaping the field of artificial intelligence.

Prof. Raphael Sznitman is the Director of the ARTORG center for Biomedical Engineering at the University of Bern (Switzerland). Raphael is interested in computational vision, probabilistic methods and statistical learning, applied to applications in medical imaging.

Instead of having a guest, Anirban and Henry just chit chats about the background stories, lessons learned, our ever-evolving thoughts etc. in the 50th episode of AI-ready Healthcare.

Prof. Nikos Paragios is a senior researcher focusing on computer vision and medical imaging. Nikos is a professor of Computer Science and Applied mathematics at CentraleSupélec, an affiliated scientific leader at INRIA while serving as the editor in chief of the Computer Vision and Image Understanding Journal. Nikos is also the founder and CEO of TheraPanacea, provider of AI-powered software for more efficient radiotherapy workflow.

Lene Topp is passionate about designing and delivering training and other capacity building activities primarily for researchers looking to increase the impact of their research in policy sectors. Until February 2023, she worked in the European Union's Joint Research Center focusing on the "Science4Policy" gap. Among many other things, she led the development of Smart4Policy researchers tool to help researchers working in science-for-policy reflect on their level of competence. .

Prof. Stefanie Speidel is a full professor for “Translational Surgical Oncology” and director at the National Center for Tumor Diseases Dresden since 2017. She is an elected board member of the MICCAI society. She is well-know for her research on Surgical Data Science, data-driven surgical training and context-aware human-machine collaboration in the operating room.