Latest Entries

1. Truthing microscope slides to validate artificial intelligence algorithms

   Entry #335

   21 May 2018

   9:45 am

   Brandon D. Gallas

   14 comments

   Hello everyone, Let me apologize for the accidental announcement earlier. It was very old. I’m contacting you now to let you know about a presentation, '' “A reader study on a 14-head microscope,” '' to be given at Pathology Informatics at 8:15am on Wednesday...

2. Announcing "High-throughput truthing" project and update on eeDAP MDDT

   Entry #322

   04 Dec 2017

   2:19 pm

   Brandon D. Gallas

   20 comments

   Greetings everyone,   It’s been a while since we last talked and I’d like to update you about what has been happening with the eeDAP studies MDDT (project description). Details about the following list are at this link...

3. Webinar on color calibration issues

   Entry #319

   22 Nov 2017

   9:02 am

   Brandon D. Gallas

   12 comments

   Upcoming webinar on color calibration issues Dec. 13, at 10am EST Speakers: Emily Clarke and Craig Revie This blog item will be updated with talk titles, abstracts, and webinar information Whole Slide Image Working Group webinar series: focus on color calibration   Dear all, I would...

4. Webinar: FDA PreCertification (Pre-Cert) Pilot Update

   Entry #318

   16 Nov 2017

   9:19 am

   Brandon D. Gallas

   12 comments

   We have a message for everyone interested in computational pathology. The FDA Pre-certification program could significantly impact regulation of computational pathology. Here is a link to information about a webinar, "FDA PreCertification (Pre-Cert) Pilot Update." November 17,...

5. Webinar Monday 10/16/17 10am EST, "Quantifying image quality of Whole Slide Imaging (WSI) scanners" by Prarthana Shrestha (Philips)

   Entry #304

   29 Sep 2017

   11:16 am

   Brandon D. Gallas

   62 comments

   Hi all, following up on our successful meeting at Pathology Informatics last May, we thought it would be interesting and educational for our WG members to organize a series of webinars on WSI-related topics.  We kick-off this effort with a talk by Philips’ Prarthana Shrestha on WSI...

6. DPA and FDA Presenting at Pathology Visions Regulatory Update: Interoperability [slides added]

   Entry #292

   23 Aug 2017

   10:08 am

   Brandon D. Gallas

   7 comments

   Slides have been attached. See links below. Greetings. I am writing to share news that the Pathology Visions Regulatory Update session will include presentations from the FDA and DPA, followed by a panel discussion. The main topic will be interoperability in the digital pathology imaging and...

7. Summer Announcements

   Entry #288

   31 Jul 2017

   2:53 pm

   Brandon D. Gallas

   11 comments

   We hope you are enjoying your summer and wanted to make a few announcements. The FDA scientists are exploring an opportunity to discuss interoperability in components of whole-slide imaging systems in the regulatory update at Pathology Visions. We'll confirm our participation once the plan...

8. WebEx Info for Meeting at Pathology Informatics, 1:30-5pm, Sunday May 21, 2017

   Entry #272

   16 May 2017

   9:48 am

   Brandon D. Gallas

   5 comments

   Agenda is HERE All audio is by telephone, not the internet. You must call in at the number below or have the system call you. Please use your name when logging in.   Meeting ID: 748 774 810 Meeting Password: 3017962531   ------------------------------------------------------- To...

9. Agenda for Face-to-Face Meeting at Pathology Informatics, 1:30-5pm, Sunday, May 21, 2017

   Entry #271

   16 May 2017

   9:30 am

   Brandon D. Gallas

   7 comments

   We have an exciting agenda for this years meeting at Pathology Informatics, see below. We hope you are planning to attend. WebEx info is HERE 4th WSI Working Group OPEN MEETING Feature studies comparing digital and microscope viewing modes: a WSI working group project @ Pathology Informatics...

10. MDDT031 Acceptance Letter

    Entry #268

    14 May 2017

    9:20 pm

    Brandon D. Gallas

    4 comments

    Success step 1! Here is the acceptance letter for eeDAP, MDDT031_Proposal_Acceptance_Incubator.pdf (154 KB). It was contained in the email below. We will discuss this letter at the face-to-face meeting at Pathology Informatics, Sunday May 21, 1:30. Please bring questions that we can pose to the...

11. "FDA's role in the innovation and evaluation of evolving computer-aided diagnosis (CAD) solutions"

    Entry #267

    14 May 2017

    2:57 pm

    Brandon D. Gallas

    4 comments

    This was a keynote talk at the SPIE Medical Imaging conference Feb, 2017. Myers_CAD_FINAL.pptx (12 MB)

12. Slides about the MDDT program at FDA's Center for Devices and Radiological Health

    Entry #266

    14 May 2017

    2:46 pm

    Brandon D. Gallas

    3 comments

    To supplement the guidance (LINK), FDA staff has put together slides outlining the program. Here are the slides MDDT_generic_slides_for_internal-external_use.pptx (3 MB)

13. Update on eeDAP Medical Device Development Tool proposal: Can we get approval with technical performance data and no reader studies?

    Entry #262

    05 May 2017

    2:59 pm

    Brandon D. Gallas

    6 comments

    This announcement is an update of our efforts to qualify eeDAP as a Medical Device Development Tool. If you are unfamiliar with this project, eeDAP, or the Medical Device Development Tool program, please refer to earlier blog items: 21 October 2017: FDA/CDRH Medical Device Development Tool 09...

14. Planning for Pathology Informatics 2017 WSIWG workshop- May 21, 2017

    Entry #259

    27 Apr 2017

    9:49 am

    MARIOS GAVRIELIDES

    4 comments

    Dear all, as you know we are getting closer to the Pathology Informatics conference and our 4th WSI workshop which gets the conference started.  A big component of the workshop this year will be updates related to eeDAP and its qualification as a Medical Device Development Tool (MDDT). ...

15. Congratulations Philips!

    Entry #245

    13 Apr 2017

    1:31 pm

    Brandon D. Gallas

    4 comments

    You may already know … FDA allows marketing of first whole slide imaging system for digital pathology https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm552742.htm   You may also already know … The WSI working group will be meeting again Sunday May 21, the...

16. Time to submit proposal: FDA/CDRH Medical Device Development Tool for digital pathology

    Entry #222

    23 Jan 2017

    3:51 pm

    Brandon D. Gallas

    8 comments

    This announcement is an update of our efforts to qualify eeDAP as a Medical Device Development Tool. If you are unfamiliar with this project, eeDAP, or the Medical Device Development Tool program, please refer to earlier blog items: 21 October 2017: FDA/CDRH Medical Device Development Tool 09...

17. Draft Proposal of FDA/CDRH Medical Device Development Tool

    Entry #217

    09 Jan 2017

    1:29 pm

    Brandon D. Gallas

    5 comments

    Happy New Year everyone. A little over two months ago we announced a project to pursue FDA/CDRH Medical Device Development Tool (MDDT) qualification of eeDAP, an evaluation environment for digital and analog pathology, and we intend to document the process with the WSI WG. Please refer to that...

18. Regulatory Challenges and Opportunities for Digital Pathology

    Entry #210

    30 Nov 2016

    9:14 am

    Brandon D. Gallas

    8 comments

    For those of you that missed Nick Anderson’s presentation at Pathology Visions in October titled, “Regulatory Challenges and Opportunities for Digital Pathology,” you can find the slides on the WSI WG site in the resources section. https://nciphub.org/resources/1927 Feel free...

19. FDA/CDRH Medical Device Development Tool

    Entry #201

    21 Oct 2016

    2:56 pm

    Brandon D. Gallas

    11 comments

    Hello all,   It has been a quiet summer for the WSI WG. We tried to get space at Pathology Visions, but we were unsuccessful. So what next?   My management has asked that I submit the tool eeDAP to the FDA/CDRH MDDT program (Medical Device Development Tool). eeDAP stands for...

20. Synopsis of meeting at Pathology Informatics, including presentations

    Entry #177

    03 Jun 2016

    2:20 pm

    Brandon D. Gallas

    4 comments

    Thanks to all that attended and contributed to our meeting at Pathology Informatics Summit last week. We are starting to reflect the "working" part of our working group. Below you will find a short synopsis of the meeting, then links to the agenda, presentation slides, and a recording...