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Congratulations to Paige.AI for obtaining Breakthrough Device designation. My recollection from a final guidance issued by the FDA late last year and taken from their own news release: "The [Breakthrough Device] program was established by the...

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...

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