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Digital Pathology Devices Panel Meeting

Digital Pathology Devices Panel Meeting. October 23, 2009 Tremel Faison, MS, RAC, SCT(ASCP). Day 1. Defined digital pathology Intended use Reference standard-light microscope IVDs that utilize digital imaging Lessons from Radiology Safety and effectiveness issues. Digital Pathology.

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Digital Pathology Devices Panel Meeting

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  1. Digital Pathology Devices Panel Meeting October 23, 2009 Tremel Faison, MS, RAC, SCT(ASCP)

  2. Day 1 • Defined digital pathology • Intended use • Reference standard-light microscope • IVDs that utilize digital imaging • Lessons from Radiology • Safety and effectiveness issues

  3. Digital Pathology • The use of computer technology to convert analog microscopic images into digital images • Whole slide imaging (WSI), aka digital imaging, virtual slides, virtual microscopy • System consisting of hardware; microscope, camera, scanner, computer, and monitor, and software. • Encompasses image acquisition, processing, archiving and retrieval

  4. Intended Use • Primary diagnosis of surgical pathology microscope slides in lieu of a microscope • Not an adjunct • Broad application (not organ or disease specific)

  5. Light microscope • Historical reference standard

  6. Regulation of digital pathology devices • FDA recognizes that the technological advances associated with WSI make its use a reality • WSI systems are not Class I exempt and are therefore, subject to premarket requirements • Current IVDs that utilize digital imaging for limited applications are not applicable to the WSI paradigm • Digital mammography may provide useful lessons but does not address all of the concerns for WSI • Our goal is to gain information about the technology in order to ensure safe and effective use

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