Royal Philips www.usa.philips.com has received regulatory clearance form FDA www.fda.gov to market its IntelliSite Solution, a digital pathology system. This is the first and currently only digital pathology system to receive clearance for primary diagnostic purposes that can be used to study digital images of surgical pathology slides.
FDA’s clearance for the digital pathology system will bring improvements in diagnosing such diseases as cancer, enable more efficient digital pathology systems to be developed, enable more teleconsultations to be conducted, and also produce more drug discoveries. One of the future major uses for the technology is to accurately produce second opinions to enable consultations.
FDA evaluated data from a clinical study of about 16,000 reads across 2,000 surgical pathology cases. One of the largest studies ever conducted to directly compare the use of digital pathology to optical microscopes took place at the Cleveland Clinic http://my.clevleandclinic.org, University of Virginia, www.virginia.edu, Miraca Life Science, www.miracalifesciences.com, and Advanced Pathology Associates www.advancedpathologyassociates.com.
All of these factors are paving the way for digital technology to gain momentum in not only the U.S but worldwide and enable digital pathology to reduce pressure on pathology services by streamlining the workflow.
However, for this to happen, standard guidelines have to be developed, regulatory concerns have to be addressed along with reimbursement issues, and lastly, how to quickly educate and train skilled personnel to use the equipment.
“The clearance for the digital pathology system not only will promote increased efficiencies and collaboration between pathologists, but also opens a complete new dimension towards computational pathology”, said Russ Granzow, General Manager of Philips Digital Pathology Solutions.