One Year of FDA Approved AI
Reflections and Predictions on the State of Clinical-Grade AI in Digital Pathology
One year after the authorization, Paige still stands alone in delivering AI quality, generalizability, and security of the caliber pathologists can trust.
In 2021, the FDA granted the first de-novo marketing authorization of an AI-powered pathology product for in vitro diagnostic (IVD) use. This marked the beginning of a new era of clinical care where pathologists can use computational pathology products like Paige Prostate Detect to enhance diagnostic accuracy and improve patient outcomes in a clinical setting.
Speakers
DR. DAVID KLIMSTRA
Founder, Chief Medical Officer
THOMAS FUCHS
Founder, Chief Scientist
EMRE GÜLTÜRK
VP, Regulatory Affairs and Quality
Join Dr. David Klimstra, Chief Medical Officer, Thomas Fuchs, Founder and Chief Scientist, and Emre Gulturk, Vice President of Regulatory Affairs and Quality as they talk through the many studies and independent validation efforts that helped to show how Paige Prostate can improve pathologist accuracy and efficiency when assessing prostate cases. They will also discuss the importance of FDA approval and the trends we have seen in the pathology space since reaching this important milestone one year ago.
LEARNING OBJECTIVES
- What makes an AI clinical grade
- Why the FDA approval is important for the digital pathology space at large
- Current trends in digital pathology and what to expect as we continue to move forward
U.S. Department of Health and Human Services
