• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    I-VASC Raises 1.8M Euros in Series A Funding

    Endotronix Shares Positive SIRONA 2 Heart Failure Trial Data

    FDA Clears Truvic's Prodigy Thrombectomy System

    Medical Device CEO Charged With Tax Evasion

    MPO's Most-Read Stories This Week—May 21
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Injecting Neurostimulators into Blood Vessels (We Swear, It’s Not Sci-Fi)

    Understanding the Costs of Care in the OR

    Sick of Being Sick: Pandemic Fatigue Flares at AAOS

    Managing Critical Healthcare Supply Chains in Turbulent Times

    To Drive Value, Human Capital Leaders Turn to Outsourced Solutions
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Fusion Biotec Inc.

    Cirtec Medical

    Xact Wire EDM Corp.

    Arthur G. Russell Co. Inc., The

    BMP Medical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3D Printing in Dental Prosthodontics, Orthodontics, and Surgery

    What New Tech Can Improve Your Medical Manufacturing Plant?

    Why Medical Device Firms Must Navigate the Muddy Waters of ESG Requirements

    Medical Device Servicing vs. Remanufacturing

    Digital Marketplaces for Medical Equipment Come of Age
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Fusion Biotec Inc.

    Cirtec Medical

    Xact Wire EDM Corp.

    Arthur G. Russell Co. Inc., The

    BMP Medical
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA Clears First Whole Slide Imaging System for Digital Pathology

    Philips IntelliSite Pathology Solution cleared for primary diagnostic use.

    FDA Clears First Whole Slide Imaging System for Digital Pathology
    Regulatory clearance was achieved via de novo classification.
    Related CONTENT
    • Medical Devices Market to Top $671.49 Billion by 2027
    • HIMSS 2021: Philips Introduces Two New HealthSuite Solutions
    • Philips, Akumin Partner to Advance Radiology Performance and Quality
    • Promaxo Taps Srirama Venkataraman as VP of Clinical Research & Strategy
    • Substantial Growth Predicted for Global Ventilators Market
    U.S. Food and Drug Administration04.13.17
    The U.S. Food and Drug Administration today permitted marketing of the Philips IntelliSite Pathology Solution (PIPS), the first whole slide imaging (WSI) system that allows for review and interpretation of digital surgical pathology slides prepared from biopsied tissue. This is the first time the FDA has permitted the marketing of a WSI system for these purposes.
     
    “The system enables pathologists to read tissue slides digitally in order to make diagnoses, rather than looking directly at a tissue sample mounted on a glass slide under a conventional light microscope,” said Alberto Gutierrez, Ph.D., Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Because the system digitizes slides that would otherwise be stored in physical files, it also provides a streamlined slide storage and retrieval system that may ultimately help make critical health information available to pathologists, other health care professionals and patients faster.”
     
    Pathologists are medical doctors who specialize in understanding the cause and development of a disease or condition. In pathology, biopsied tissues are mounted onto glass slides and stained for viewing and evaluation. The PIPS uses proprietary hardware and software to scan and digitize conventional surgical pathology glass slides prepared from biopsied tissue at resolutions equivalent to 400 times magnification. These digitized images can then be reviewed and interpreted by pathologists.  
     
    The FDA reviewed the data for the PIPS through the de novo premarket review pathway, a regulatory pathway for devices of a new type with low- to moderate-risk that are not substantially equivalent to an already legally marketed device. The FDA evaluated data from a clinical study of approximately 2,000 surgical pathology cases using tissue from multiple parts of the body (anatomic sites). Results of the study found that clinical interpretations (diagnoses) made based on the PIPS images were comparable to those made using glass slides.
     
    In this authorization, the FDA is establishing special controls that must be met to assure the digital imaging system’s precision, reliability, and clinical relevance. The risks associated with use of this technology are similar to that of the use of conventional light microscopy. These special controls are necessary to provide reasonable assurance of safety and effectiveness for this digital imaging system. 
     
    The FDA permitted marketing of the Philips IntelliSite Pathology Solution to Philips Medical Systems Nederland B.V.
    Related Searches
    • fda
    • health
    • data
    • first
    Related Knowledge Center
    • Diagnostics
    • Software & IT
    • Digital Health
    Suggested For You
    Medical Devices Market to Top $671.49 Billion by 2027 Medical Devices Market to Top $671.49 Billion by 2027
    HIMSS 2021: Philips Introduces Two New HealthSuite Solutions HIMSS 2021: Philips Introduces Two New HealthSuite Solutions
    Philips, Akumin Partner to Advance Radiology Performance and Quality Philips, Akumin Partner to Advance Radiology Performance and Quality
    Promaxo Taps Srirama Venkataraman as VP of Clinical Research & Strategy Promaxo Taps Srirama Venkataraman as VP of Clinical Research & Strategy
    Substantial Growth Predicted for Global Ventilators Market Substantial Growth Predicted for Global Ventilators Market
    Royal Philips Enters Strategic Partnership with NICO.LAB Royal Philips Enters Strategic Partnership with NICO.LAB
    Enrollment Underway in Philips Enrollment Underway in Philips' WE-TRUST Stroke Study
    Philips Recalls Certain Sleep and Respiratory Care Devices Philips Recalls Certain Sleep and Respiratory Care Devices
    Philips, Ibex Medical Analytics Partner to Accelerate Adoption of AI-Powered Digital Pathology Philips, Ibex Medical Analytics Partner to Accelerate Adoption of AI-Powered Digital Pathology
    Philips, UCSF Team Up to Enhance Digital Patient Experience Philips, UCSF Team Up to Enhance Digital Patient Experience
    Neuronetics Appoints Robert Cascella to its Board of Directors Neuronetics Appoints Robert Cascella to its Board of Directors
    Paige Appoints Chief Commercial Officer and Medical Director Paige Appoints Chief Commercial Officer and Medical Director
    Connect America to Buy Philips Connect America to Buy Philips' Aging and Caregiving Biz
    PENTAX Appoints Former Philips VP Ojas A. Buch as President, Americas PENTAX Appoints Former Philips VP Ojas A. Buch as President, Americas
    Device Companies to Help AI Market Reach $52 Billion in 2024 Device Companies to Help AI Market Reach $52 Billion in 2024

    Related Content

    • Medical Devices Market to Top $671.49 Billion by 2027

      Medical Devices Market to Top $671.49 Billion by 2027

      Wearables and rising cases of chronic diseases will help fuel growth, industry data predicts.
      Precedence Research 09.16.21

    • Digital Health | Software & IT
      HIMSS 2021: Philips Introduces Two New HealthSuite Solutions

      HIMSS 2021: Philips Introduces Two New HealthSuite Solutions

      Cloud-based solutions for orchestrated patient logistics and enterprise telehealth for acute care.
      GlobeNewswire 08.09.21

    • Philips, Akumin Partner to Advance Radiology Performance and Quality

      Philips, Akumin Partner to Advance Radiology Performance and Quality

      Partnership leverages Philips’ Radiology Operations Command Center to improve the access, quality, productivity of Akumin’s outpatient imaging center network.
      Royal Philips 08.05.21


    • Promaxo Taps Srirama Venkataraman as VP of Clinical Research & Strategy

      Promaxo Taps Srirama Venkataraman as VP of Clinical Research & Strategy

      With previous roles at Philips and Stryker, Dr. Venkataraman will bring his expertise to Promaxo’s MRI and robotic platform.
      Business Wire 07.30.21

    • Substantial Growth Predicted for Global Ventilators Market

      Substantial Growth Predicted for Global Ventilators Market

      Aging population, increasing infectious disease rates to drive growth through 2026.
      Market Study Report 07.13.21


      Trending
      • Quality Management Evolution: What to Expect in 2022
      • 5 Ways Plastics Revolutionized The Healthcare Industry | Medical Product Outsourcing
      • 7 Steps To Create Your Own Medical Device Marketing Plan | Medical Product Outsourcing
      • MPO's Most-Read Stories This Week—May 21 | Medical Product Outsourcing
      • Quality Management Evolution: What To Expect In 2022 | Medical Product Outsourcing
      Breaking News
      • I-VASC Raises 1.8M Euros in Series A Funding
      • Endotronix Shares Positive SIRONA 2 Heart Failure Trial Data
      • FDA Clears Truvic's Prodigy Thrombectomy System
      • RSIP Vision Develops New AI Tool for Prostate MRI Analysis
      • Medical Device CEO Charged With Tax Evasion
      View Breaking News >
      CURRENT ISSUE

      May 2022

      • Cybersecurity Challenges Leave Medical Device Makers Insecure
      • Contract Design for Medtech
      • Diabetes Medical Device Technology Update
      • Medtech Full-Service Outsourcing Q&A 2022

      Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
      You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

      • About Us
      • Privacy Policy
      • Terms And Conditions
      • Contact Us

      follow us

      Subscribe
      Nutraceuticals World

      Latest Breaking News From Nutraceuticals World

      Vitafoods Europe 2022 Attendance Returns to 2019 Level
      Beyond Raw Launches Concept X Pre-Workout Line
      Botanical Ingredient MorActive Evidenced to Relieve Back Discomfort
      Coatings World

      Latest Breaking News From Coatings World

      PPG’s Diane Kappas Recognized as ‘Woman of Influence’ by Pittsburgh Business Times
      BEHR Launches COPPER FORCE Interior Paint
      A New Kind of Primer: Demand for Interior and Exterior Paint Experts Remains High, J.D. Power Finds
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      I-VASC Raises 1.8M Euros in Series A Funding
      Endotronix Shares Positive SIRONA 2 Heart Failure Trial Data
      FDA Clears Truvic's Prodigy Thrombectomy System
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Thermo Fisher, Qatar Genome Program Partner to Advance Precision Medicine
      CPC Launches AseptiQuik Genderless Connector
      Aptamer Group and PinotBio Extend Collaboration Agreement
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      L’Oréal USA Names Han Wen as Chief Digital & Marketing Officer
      NPD Group Reports on Rising E-commerce Sales in China for Prestige Beauty
      Noon Aesthetics Celebrates Ten Years with New Skincare Products
      Happi

      Latest Breaking News From Happi

      Gabriel Letizia Jr. Sentenced to 60 Months in Prison for Falsifying Sunscreen Test Results
      Coptis Appoints Marie Renee Thadal Vice President of Sales and Operations
      Han Wen Appointed L’Oréal’s New Chief Digital, Marketing Officer
      Ink World

      Latest Breaking News From Ink World

      Weekly Recap: Zeller+Gmelin, Sun Chemical and Kornit Top This Week’s News
      Nazdar Celebrates 100 Years with a New Look
      hubergroup Chemicals Exhibits at Paint India for First Time
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      Avery Dennison announces Core Series Portfolio Tape Selector App
      HP Indigo reaches 2,000th active install milestone
      Brook + Whittle's new acquisition, SunDance goes to HP and more
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Ahlstrom-Munksjö Announces Reorganization of Decor Business Ownership
      Jones Names COO
      Ontex Conducts Pilot Program of Digital Incontinence Care Solution
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Tom Hedman Named Senior Principal Scientist at Spinal Simplicity
      ODT's Most Read Stories This Week—May 21
      FDA Clears Anika Therapeutics' X-Twist Knotless Fixation System
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Weekly Recap: Graphene Flagship, Japan Display and LG Display Top This Week’s Stories
      Evonik Launches New Processing Aids for PV Wafer Cutting
      NREL Creates Highest Efficiency 1-Sun Solar Cell

      Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

      AD BLOCKER DETECTED

      Our website is made possible by displaying online advertisements to our visitors.
      Please consider supporting us by disabling your ad blocker.


      FREE SUBSCRIPTION Already a subscriber? Login