• Skip to main content
  • Skip to secondary menu
  • Skip to primary sidebar
  • Skip to secondary sidebar
  • Skip to footer

  • Opinion
  • Health IT
    • Behavioral Health
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Patient Engagement
    • Population Health Management
    • Revenue Cycle Management
    • Social Determinants of Health
  • Digital Health
    • AI
    • Blockchain
    • Precision Medicine
    • Telehealth
    • Wearables
  • Life Sciences
  • Investments
  • M&A
  • Value-based Care
    • Accountable Care (ACOs)
    • Medicare Advantage

Philips Awarded FDA Clearance for Digital Pathology Solution for Primary Diagnostic Use

by Jasmine Pennic 04/13/2017 Leave a Comment

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Massachusetts General Hospital Launches Digital Pathology Study

Today, Philips announced it has received regulatory clearance from the FDA (via De Novo classification) for its IntelliSite Pathology Solution, marking a significant leap forward for the pathology services industry in the U.S.  De novo classification is the regulatory pathway for marketing clearance for novel, low- to moderate-risk medical devices that are the first of their kind

As the first and only digital pathology system to be approved for primary diagnostic use in the country, today’s news has implications not only for improving laboratory workflow and efficiencies, but also for improving the quality and accuracy of cancer diagnostics through computational pathology—an approach to rendering disease diagnoses that incorporates multiple sources of data and uses mathematical models to generate clinically actionable inferences.

Philips IntelliSite Pathology Solution is an automated digital pathology image creation, viewing and management system comprised of an ultra-fast pathology slide scanner, an image management system and a display. This solution is complemented by advanced software tools to manage the scanning, storage, presentation, reviewing, and sharing of information. By supporting the transition to digital workflows, Philips seeks to help pathology laboratories simplify access to histopathology information and help staff work more efficiently.

The FDA evaluated data from a clinical study of approximately 2,000 surgical pathology cases. This was one of the largest studies ever conducted to directly compare the use of digital pathology to optical microscopes. Sixteen pathologists at four clinical study sites – Cleveland Clinic, University of Virginia, Miraca Life Sciences and Advanced Pathology Associates – conducted approximately 16,000 reads across 2,000 cases. FDA’s news release ‘FDA allows marketing of first whole slide imaging system for digital pathology’ can be found here.

Pathology services are under pressure to meet the increasingly complex demands of cancer care. As the number of cancer cases continue to grow, the complexity and number of tests have simultaneously increased to support improved patient care. Pathologists must work as efficiently and effectively as possible to analyze the complex information that influences the design of personalized treatments. Outside the U.S., where CE-IVD mark has allowed primary diagnosis since 2014, digital pathology is recognized for increased efficiencies in the logistics and consultation needs in primary diagnosis of histopathology images. 

It is an exciting time in pathology as paradigm shifts are being witnessed in cancer care with precision medicine and personalized treatments increasing by the day – pathologists are absolutely central to this dream of personalized medicine.

“The clearance for Philips IntelliSite Pathology Solution marks a major milestone for innovation in pathology services in the U.S.,” said Russ Granzow, General Manager of Philips Digital Pathology Solutions. “Not only will it promote increased efficiencies and collaboration between pathologists, but it also opens a complete new dimension towards computational pathology which aims to increase accuracies and ultimately enhance patient care.”

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Tagged With: De novo classification, FDA Clearance, IntelliSite Pathology Solution, Philips, Philips’ IntelliSite Solution

Tap Native

Get in-depth healthcare technology analysis and commentary delivered straight to your email weekly

Reader Interactions

Primary Sidebar

Subscribe to HIT Consultant

Latest insightful articles delivered straight to your inbox weekly.

Submit a Tip or Pitch

Featured Insights

Digital Health Funding Q3 2025: Choppy Undercurrents Beneath a Steady Surface

Most-Read

Qualtrics Acquires Press Ganey Forsta for $6.75B to Create the Most Comprehensive AI Experience Platform

Qualtrics Acquires Press Ganey Forsta for $6.75B to Create the Most Comprehensive AI Experience Platform

Pfizer and Trump Administration Announce Landmark Agreement to Lower Drug Costs

Pfizer and Trump Administration Announce Landmark Agreement to Lower Drug Costs

KLAS Report: Epic's Native Ambient Speech Tool Reshapes Customer AI Strategies

KLAS Report: Epic’s Native Ambient Speech Tool Reshapes Customer AI Strategies

Epic Unveils MyChart Central and New APIs to Advance Interoperability at Open@Epic

Epic Outlines Roadmap for Next-Generation Data Sharing at Open@Epic

Epic Launches Comet: A New AI Platform to Predict Patient Health Journeys

Epic Launches Comet: A New AI Platform to Predict Patient Health Journeys

RevSpring to Acquire Kyruus Health, Creating a Unified Patient Experience

RevSpring to Acquire Kyruus Health, Creating a Unified Patient Experience

Oracle Confirms Layoffs in Kansas City

Oracle Confirms Layoffs in Kansas City

Philips Future Health Index 2025: AI and Digital Tech Can Help Solve Cardiac Care Crisis

Philips Future Health Index 2025: AI and Digital Tech Can Help Solve Cardiac Care Crisis

Optain Health Secures $26M to Advance AI-Powered Retinal Screening

Optain Health Secures $26M for AI-Powered Retinal Screening

Sutter Health and Epic Launch "Sutter Sync" to Optimize Remote Chronic Care

Sutter Health and Epic Launch “Sutter Sync” to Optimize Remote Chronic Care

Secondary Sidebar

Footer

Company

  • About Us
  • Advertise with Us
  • Reprints and Permissions
  • Submit An Op-Ed
  • Contact
  • Subscribe

Editorial Coverage

  • Opinion
  • Health IT
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Population Health Management
    • Revenue Cycle Management
  • Digital Health
    • Artificial Intelligence
    • Blockchain Tech
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • Value-Based Care
    • Accountable Care
    • Medicare Advantage

Connect

Subscribe to HIT Consultant Media

Latest insightful articles delivered straight to your inbox weekly

Copyright © 2025. HIT Consultant Media. All Rights Reserved. Privacy Policy |