Tag: FDA

FDA Technical Guidance Document Does Not Go Far Enough

| May 13, 2016 | 0 Comments

As many readers are aware, on April 20th the FDA released its Technical Guidance Document for Digital Pathology Whole Slide Imaging Devices after draft proposal/review from February of last year. Given its title, this is a technical document, obviously. However, in my opinion, the document, beginning with draft to this finished product, I am sure despite comments to […]

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FDA’s Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices

| May 10, 2016 | 0 Comments

WHAT DOES IT MEAN TO ME? The Digital Pathology Association 2016 Webinar Series – Session 2 Available to Members Only Thursday, May 25, 2016 | 1pm EST Learn more about the newly released FDA Guidance for Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices. What does it mean to you? Members of the DPA […]

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The Unleashed Power of Digital Pathology: Is There a Way Forward?

| March 29, 2016 | 0 Comments

The featured post for today is guest written by Dr. Anil Parwani, known throughout the industry as a key opinion leader and has been very active in digital pathology among many other professional and research interests. In his post he looks back 15 years to our first meeting at a pathology meeting, perhaps in a […]

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Digital Pathology Association Acknowledges Collaborative Efforts with FDA for Whole Slide Imaging

| February 20, 2016 | 0 Comments

The Digital Pathology Association (DPA) recently announced its suggestion that digital pathology manufacturers currently interested in marketing Whole Slide Imaging (WSI) devices for primary diagnosis in the United States submit de novo applications to the Food and Drug Administration (FDA) based on clarity and guidance provided to the DPA from the FDA. WSI technology is critical to advancement […]

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Omnyx Applauds FDA and Digital Pathology Association on Recent Collaboration 

| January 17, 2016 | 0 Comments

Last week news was released after months of speculation, that the FDA would consider the de novo classification option for digital pathology systems as a pathway for bringing to market a moderate or low risk device which has not yet been classified, and for which there is no predicate device (as in whole slide imaging systems). If the FDA […]

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DPA Recommends Whole Slide Imaging Manufacturers Submit De Novo Applications to the FDA for Primary Diagnosis

| January 14, 2016 | 0 Comments

Collaboration with FDA Results in Opportunity for Streamlined Approval Process The Digital Pathology Association (DPA) announced today that it suggests digital pathology manufacturers currently interested in marketing whole slide imaging (WSI) devices for primary diagnosis in the United States submit de novo applications to the Food and Drug Administration (FDA). WSI is a technology which […]

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Further Rejection of Null Hypothesis: Digital Pathology Equal to Glass Slides

| December 21, 2015 | 0 Comments

Since the inception of commercially available whole slide imaging systems more than 15 years ago, a necessary requirement has been to prove that diagnoses made using DP alone are equal to or better than conventional glass slides (GS) that have been used for at 10 times longer to care for patients. That is to say, […]

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Digital Pathology Story Appears in Wall Street Journal

| June 9, 2015 | 1 Comment

Facebook and a number of folks last night during a bad time for the Chicago Blackhawks made me aware of a piece by Ms. Landro at the Wall Street Journal that touches on a number of issues including mention of use of digital pathology for image analysis as illustrated by work being done at UPMC with […]

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Flagship Biosciences Customizes Assay Development and Tissue Image Analysis for Advanced Cell Diagnostics RNAscope Platform

| April 18, 2015 | 0 Comments

April 16, 2015, Westminster CO — Flagship Biosciences, the leading service provider of digital pathology solutions, announced today the utilization of its wet assay development and image analysis quantification capabilities for RNAscope® RNA in situ hybridization (ISH) from Advanced Cell Diagnostics, Inc. (ACD), a technology and market leader in the field of molecularpathology and developer of […]

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Digital pathology and The Big Cs (That’s ‘Cancer’ and ‘Cloud’)

| April 6, 2015 | 0 Comments

Came across this interesting article in a couple of places over past couple days including from The Register, among other sources.  Couple of points strike me here, namely, that I didn’t know that TIME magazine, in addition to The New York Times and other media sources that I mentioned in my previous post on March […]

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FDA Announces Availability of Draft Guidance on WSI Devices

| February 24, 2015 | 0 Comments

Download here (available from Federal Register 2/25/2015) PDF of Draft Guidance Document The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled “Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices.” This draft guidance provides industry and Agency staff with recommendations regarding the technical performance assessment data that should […]

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Making Clinical Diagnosis Picture-Perfect the Focus at Huron Digital Pathology

| February 16, 2015 | 0 Comments

Readers may have noticed recently Huron Digital Pathology has rebranded itself from Huron Technologies and Biomedical Photometrics prior to that.  Their new logo on the right sidebar reflects their continued focus on manufacturing reliable scanning technologies within digital pathology.  More company history and news is contained in the press release below.  Check out their revamped website […]

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Applied Spectral Imaging receives FDA Clearance for GenASIs™ HiPath IHC Family for HER2, ER, PR and Ki67

| January 22, 2015 | 0 Comments

Carlsbad, CA. – January 21, 2015 – Applied Spectral Imaging (ASI, www.spectral-imaging.com) announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its GenASIs HiPath image capture and analysis platform. ASI’s GenASIs HiPath IHC Family is an advanced image analysis platform for IHC and CISH samples that integrates with existing lab […]

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Time For FDA to Act is Now

| October 28, 2014 | 0 Comments

Drs. Parwani, Hassell, Glassy and Pantanowitz have an excellent editorial entitled “Regulatory barriers surrounding the use of whole slide imaging in the United States of America” in the most recent edition of the Journal of Pathology Informatics (J Pathol Inform 2014;5:38). I think their summary below sums up very nicely the time for FDA to act […]

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