Speaker Profile

MBA, Associate Director for Digital Health, Center for Devices and Radiological Health, FDA

Biography
Bakul Patel is Associate Director for Digital Health, at the Center for Devices and Radiological Health (CDRH), at the Food and Drug Administration (FDA). Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, health information technology, cyber security, medical device interoperability, and medical device software. Mr. Patel is the FDA liaison between the Federal Communications Commission (FCC) and the Office of the National Coordinator (ONC). Since its inception in 2013, Bakul chairsthe International Medical Device Regulators Forum (IMDRF) “software as a medicaldevice” working group, a global harmonization effort. Before joining FDA, Mr. Patel held key leadership positions working in the telecommunications industry, semiconductor capital equipment industry, wireless industry and information technology industry. His experience includes Lean Six Sigma, creating long and short‐term strategy, influencing organizational change, modernizing government systems, and delivering high technology products and services in fastpaced, technology‐intensive organizations. Mr. Patel earned an MS in Electronic Systems Engineering from the University of Regina, Canada, and an MBA in International Business from The Johns Hopkins University.


 Session Abstract – PMWC 2022 Silicon Valley


Track Chairs:
Sharmila Majumdar, UCSF
Matthew Lungren, Stanford

The use of Artificial Intelligence (AI) in diagnostic medical imaging is undergoing extensive evaluation. AI has shown impressive accuracy and sensitivity in the identification of imaging abnormalities and promises to enhance tissue-based detection and characterization. This track will explore technical advancements in clinical machine learning and use cases in radiology.

Sessions:

  • Regulatory Considerations for AI & Machine Learning in Medical Imaging
    - Bakul Patel, FDA
    - Sean Khozin, CancerLinQ
  • AI Roadmap: Opportunity and Challenges
    Session Chair: Sean Khozin, CancerLinQ
    - Brandon Allgood, Valo Health
    - Patrick Loerch, Gilead
    - Daniel J. Arbess, Xerion Investments LLC
    - Matthew Lungren, Stanford
  • Technical Advancements in Clinical Machine Learning - What's New in 2021
    Session Chair: Sharmila Majumdar, UCSF
    - Matthew Lungren , Stanford
    - Jayashree Kalpathy-Cramer, Harvard
    - John Mongan, UCSF
  • Image Applications for Clinical Diagnosis
    Session Chair: Lawrence Schwartz, Columbia University Medical Center
    - Thorsten Fleiter, U. of Maryland
    - Imon Banerjee, Mayo Clinic
    - Anant Madabhushi, Case Western Reserve University
    - Pratik Mukherjee, UCSF
    - Esther L. Yuh, UCSF
  • Session TBA
    - Christopher Coley, Epredia
  • Evaluation of AI Software for Radiological Applications
    Session Chair: Kyung Hyun Sung, UCLA
    - Akshay Chaudhari, Stanford
    - Mona Flores, NVIDIA
  • PMWC 2022 Showcase (NCI)
    - Eric Horler, AIQ Solutions