• 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
  • Startups
  • M&A
  • Value-based Care
    • Accountable Care (ACOs)
    • Medicare Advantage
  • Life Sciences
  • Research

PathAI Granted FDA Clearance for AISight Dx for Primary Diagnosis in Clinical Settings

by Fred Pennic 07/01/2025 Leave a Comment

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print
PathAI Granted FDA Clearance for AISight Dx

What You Should Know: 

– PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its digital pathology image management system, AISight® Dx, for use in primary diagnosis in clinical settings.

– The FDA clearance builds upon the platform’s initial 510(k) clearance for AISight Dx(Novo) in 2022, demonstrating PathAI’s ongoing commitment to innovation and delivering enhanced capabilities.

Accelerated Innovation Through Predetermined Change Control Plan

The FDA’s decision also included a Predetermined Change Control Plan (PCCP). This critical regulatory alignment allows PathAI to validate and implement specified major changes, such as additional displays, scanners, file formats, and browsers, into AISight Dx without requiring further 510(k) submissions. The approach is expected to accelerate future software updates and hardware integrations, enabling faster innovation while ensuring continued FDA compliance.

Maximizing Efficiency in Anatomic Pathology Workflows

AISight Dx is a cloud-native digital pathology platform meticulously designed to maximize efficiency in anatomic pathology workflows. The system offers a comprehensive suite of features, including intelligent case management, high-performance slide review, and seamless live collaboration. These capabilities help laboratories accelerate turnaround times and optimize pathologist productivity.

With integrated image management, synchronized multi-slide navigation, and robust annotation tools, AISight Dx aims to eliminate manual bottlenecks and support faster, more consistent diagnoses. The platform is built for interoperability, compliance, and scale, empowering anatomic pathology labs, hospital systems, and academic medical centers to modernize their operations and confidently deliver high-quality patient care.

“Digital pathology is the future of diagnostic medicine, empowering pathologists to work more efficiently and collaborate quickly without being limited to physical specimen review,” said Andy Beck, M.D., Ph.D., CEO of PathAI. “

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Tagged With: FDA Clearance, FDA clearance 510k

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

 Selecting the Right EMR: A Practical Guide to Streamlining Your Practice and Enhancing Patient Care

Selecting the Right EMR: A Practical Guide to Streamlining Your Practice and Enhancing Patient Care

Featured Interview

Virta Health CEO: GLP-1s Didn’t Kill Weight Watchers, Its Broken Model Did

Most-Read

Health IT Sector Navigates Policy Turbulence with Resilient M&A

Health IT’s New Chapter: IPOs Return, Resilient M&A, Valuations Rise in 1H 2025

PwC Report: US Medical Cost Trend to Remain Elevated at 8.5% in 2026

PwC Report: US Medical Cost Trend to Remain Elevated at 8.5% in 2026

Philips Launches ECG AI Marketplace, Partnering with Anumana to Enhance Cardiac Care with AI-Powered Diagnostics

Philips Launches ECG AI Marketplace, Partnering with Anumana to Enhance Cardiac Care with AI-Powered Diagnostics

WeightWatchers Emerges from Bankruptcy, Launches New Menopause Program

WeightWatchers Emerges from Bankruptcy, Launches New Menopause Program

CMS Finalizes New Interoperability and Prior Authorization Rule

CMS Proposes 2026 Physician Fee Schedule Rule: Boosting Primary Care, Cutting Waste, and Modernizing Payments

Beyond SaaS: How Agent as a Service is Transforming Healthcare Automation

Beyond SaaS: How Agent as a Service is Transforming Healthcare Automation

New Strategies Needed: No Surprises Act and the Challenges for Payors with Provider Data Inaccuracies

Samsung Acquires Xealth to Accelerate Connected Care Vision

Samsung Acquires Xealth to Accelerate Connected Care Vision

AI Dominates Digital Health Investment in First Half of 2025

Rock Health Report: AI Dominates Digital Health Investment in First Half of 2025

Moving Beyond EHRs: What Lies Ahead for Healthcare Digitization?

AI Agents vs. Chatbots: Understanding Agentic AI’s Role in Healthcare

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 |