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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...

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...

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...

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...

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...

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