Tag: Medical Device Development Tool

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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