Tag: regulation

WSI Device Clearances After the Philips De Novo Classification: An Outlook on the Regulatory Road Ahead

| September 22, 2017 | 0 Comments

By Christopher Ivicevich, Director of Regulatory Affairs & Quality Compliance, OptraSCAN With the recent shift in the industry as the result of this decision, a common question is “What lies in store for digital pathology system manufacturers in the wake of the FDA granting Philips’ de novo classification request for its IntelliSite device?” First, What […]

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What does FDA Approval Mean for the Digital Pathology Market? Part 1

| May 15, 2017 | 0 Comments

Much is being said, written and discussed about the recent FDA clearance for Philips digital pathology solution for primary surgical pathology diagnosis. Of course, this means an advantage for Philips right now in the market as the only FDA approved whole slide imaging system for primary diagnosis. For groups and hospitals that appreciate the two main […]

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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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Patients Advocating for Pathologists

| November 11, 2015 | 0 Comments

I recently came across these statements: The issues set forth herein must be further explored to ensure that patients are receiving appropriate care based on accurate diagnoses and accurate identification of predictive and prognostic markers. A pathologic diagnosis is the foundation upon which all other treatment decisions are made and with breast cancer, the pathology […]

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Some Health Apps to be Regulated by the FDA

| September 24, 2013 | 0 Comments

The New York Times (9/24, A12, Tavernise, Subscription Publication) reports that the Food and Drug Administration announced on Monday that “a small portion of the rapidly expanding universe of mobile health applications” would be regulated by the agency. FDA officials said the “goal is to oversee apps that function like medical devices, performing ultrasounds, for example, and that could […]

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