Footnotes
The Philips Digital Pathology solution is a bundle of: Pathology Scanner Second Generation SG20/ SG60/ SG300 • Image Management System Viewer • Image Management System Application Server and Storage Software • High quality 27” monitor validated with the IVD solution (US only)
* Philips IntelliSite Pathology Solution (PIPS) can be used for in vitro diagnostic purposes. The system can aid pathologists to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. PIPS is not available for sale in all countries. PIPS enables iSyntax files with SDK; third-party companies can use this for AI capabilities. The Software Development Kit (SDK) and File Viewer is not intended for diagnostic, monitoring or therapeutic purposes or in any other manner for regular medical practice.
Philips was the world’s first vendor to release an in vitro diagnostic (IVD)-labeled digital pathology system (both CE-IVD in 2013 and an FDA De Novo clearance in 2017).
1. Philips digital pathology solution in combination with the Ibex AI: Raoux, et al. Modern Pathology (2021) 34 (suppl 2): 598-599.
2. FDA.gov - FDA allows marketing of first whole slide imaging system for digital pathology - https://www.fda.gov/news-events/press-announcements/fda-allows-marketing-first-whole-slide-imaging-system-digital-pathology
3. PIPS enables iSyntax files and with the Software Development Kit (SDK), third-party companies can use this for AI capabilities.
4. Survey of 52 pathologists, lab managers and lab technicians in Europe, 2018.