Tag: FDA

162 Days of Change

| April 17, 2017 | 0 Comments

As of last Thursday, April 12, 2017 and going back to a rainy night in Cleveland on November 2, 2016, the past 162 days have seen at least 3 things most Americans, and perhaps many across the world thought they would never see happen in their lifetimes. That rainy night in Cleveland started the clock […]

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FDA Allows Marketing of First Whole Slide Imaging System for Digital Pathology

| April 13, 2017 | 1 Comment

Welcome news anticipated from FDA for some time with recent Philips submission for approval. Philips Intellisite Pathology Solution (PIPS) first WSI system approved with special controls on the system to insure patient safety. More to follow on FDA approval of WSI for clinical use! The U.S. Food and Drug Administration today permitted marketing of the […]

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Inspirata Seeking Senior Vice President, Cancer Diagnostics Software Products

| March 27, 2017 | 0 Comments

The Sr. Vice President—Cancer Diagnostics Software Products should be a highly-experienced business leader with exceptional deep knowledge and understanding of digital image processing software domain and proven sales and marketing experience. This leader will be responsible for the execution of the company’s business strategy for the cancer diagnostics software algorithm business unit including regulatory and […]

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FDA Delays Final Guidance on Regulating LDTs

| November 25, 2016 | 0 Comments

medpagetoday.com posted a brief but concise article earlier this week on the issue of FDA regulating laboratory developed tests (LDTs). While the FDA has had the ability to regulate these tests since 1976, largely once regarded as “simple and scarce” as the article mentions, not before a draft guidance issued in 2014 has the FDA […]

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Multi-Center Clinical Validation Study by Philips to be Submitted to FDA in Support of Expanded Indications for Use for Philips IntelliSite Digital Pathology Solution in the U.S.

| October 24, 2016 | 0 Comments

Great news from Philips who announced on October 21st their completion of a glass versus digital concordance study to be submitted to FDA.  The press release mentions 2,000 cases with approximately 16,000 reads. The press release goes on to say that the final discordance rate was 1%. Philips will submit the results of the study along […]

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FDA Approves First Liquid Biopsy Test for Use in Non-Small Cell Lung Cancer

| June 1, 2016 | 0 Comments

Exciting news today from FDA with news of approval of first liquid biopsy test for use in non-small cell lung cancer.  The cobas EGFR test is already approved for use in formalin-fixed paraffin-embedded (FFPE) tissue. This new use is intended for detection of these specific mutations in circulating-free tumor DNA (cfDNA) from plasma for first […]

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FDA Grants Accelerated Approval to Nivolumab in Classical Hodgkin Lymphoma

| May 17, 2016 | 0 Comments

More interesting news around PD-L1 for use in Classical Hodgkin lymphoma with specific indications as below. Another increasingly common example of companion diagnostics and personalized immunotherapies. On May 17, 2016, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo; Bristol-Myers Squibb) for the treatment of patients with classical Hodgkin lymphoma that has […]

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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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