Update from MSKCC
- How many reads are complete? 4 pathologists have completed the first session: half the reads on the microscope and half the reads on the digital display eeDAP launches !ImageScope.
- Scheduling Northwell: Jim Crawford and colleagues… in progress
Faster eeDAP studies
- Two pathologists at one time, sharing the microscope: This protocol has two concerns for bias (Brandon): chatting about the image and looking at the digital image. Joe indicated that the discussion can be controlled. It might be harder to control looking at the digital image. Would reviewers be critical of this protocol?
- Skipping the registration: This could work. FDA is working on registration accuracy when it is not performed before the study; use the last registration results, perhaps leave the slides on the stage.
- 14-head microscope: This is an exciting idea. Brandon has requested has some travel money to send Qi back to NY to install eeDAP on the 14-head microscope at MSKCC for a one- or two-day study.
Discussion is started here.
FDA will be attending to discuss interoperability within a digital pathology scan-display product either during the DICOM Connect-a-thon or during the regulatory panel.