Congratulations to the clinical trial and regulatory teams at Precision for Medicine: The FDA has just announced that the Philips PIPS (Philips IntelliSite Pathology Solution) has been approved through the de novo premarket review pathway as the first digital pathology solution for primary diagnostic use in the US.
This regulatory clearance signals a significant leap forward for the pathology services industry, and is expected to greatly boost adoption of digital pathology and collaboration.
Precision provided instrumental support to Philips in achieving this approval, monitoring the pivotal trial and working directly on the FDA strategy, including the successful effort to down-classify the system from a PMA Class III device to a Class II device (representing devices of a new type with low-to-moderate risk). This down-classification not only shortened the review time, but also reduces the regulatory burden going forward and streamlines the process for bringing incremental innovations to the US market.
For more information, click the link below to view the FDA press release.