• 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

Annalise.ai Receives FDA Clearance for Radiology Triage Device

by Syed Hamza Sohail 09/14/2023 Leave a Comment

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

What You Should Know:

  • Annalise.ai, a leader in AI-powered medical imaging solutions, announced the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the triage and notification of obstructive hydrocephalus (OHCP) on non-contrast brain CT scans.
  • Annalise.ai has also received FDA Breakthrough Device Designation for its obstructive hydrocephalus software tool. This is the first radiology triage device to be granted Breakthrough status since the inception of the FDA Breakthrough Devices Program*.

AI-Driven Paradigm Shifts in Neuro-Radiology

The FDA’s Breakthrough Devices Program identifies medical devices that improve the treatment or diagnosis of life-threatening or debilitating conditions. It aims to grant quick access to these devices to healthcare providers. To be authorized for marketing, these devices must meet the FDA’s strict safety and effectiveness standards.

Annalise.ai’s cutting-edge solution enables both passive and active notifications for suspected OHCP cases identified on unenhanced head CT scans. The newly cleared algorithm bolsters Annalise.ai’s U.S. portfolio to a total of ten FDA-cleared findings – five for chest X-rays (CXR) and five for head CT scans (CTB), positioning Annalise.ai as a provider of one of the U.S.’s most comprehensive FDA-cleared AI triage solutions.

Lakshmi Gudapakkam, CEO of Annalise.ai, stated: “Our FDA clearances, including this latest addition, underscore our dedication to revolutionizing medical imaging. Annalise.ai is proud to offer a comprehensive suite of AI solutions that significantly enhance diagnostic capabilities and assist in delivering prompt, life-saving interventions for conditions like obstructive hydrocephalus.”

Obstructive hydrocephalus, a potentially life-threatening condition, involves the accumulation of cerebrospinal fluid in the cranial vault, leading to elevated intracranial pressure that can escalate rapidly if left untreated. The Breakthrough Device Designation from the FDA highlights Annalise.ai’s commitment to expediting patient access to advanced medical solutions that address critical healthcare needs.

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Tagged With: FDA Clearance

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

HLTH 2025 Coverage

HLTH 2025 Day 1 Summary & Insights: AMA Launches AI Governance Center, Google Cloud, Microsoft, ChatGPT for Medicine

Featured Interview

ConcertAI VP Shares View on AI Hallucinations and the Fabricated Data Crisis in Scientific Publishing

Most-Read

Cleveland Clinic and Khosla Ventures Form Strategic Alliance to Accelerate Healthcare Innovation

Cleveland Clinic and Khosla Ventures Form Strategic Alliance to Accelerate Healthcare Innovation

Northwell Health Selects to Deploy Abridge’s Ambient AI Across 28 Hospitals

Northwell Health to Deploy Abridge’s Ambient AI Across 28 Hospitals

Omada Health Launches "Nutritional Intelligence" with AI Agent OmadaSpark

Omada Health Launches AI-Powered Meal Map to Transform Nutrition for Cardiometabolic Patients

From Overwhelmed to Optimized: How AI Agents Address Staffing Challenges and Burnout in Healthcare

From Overwhelmed to Optimized: How AI Agents Address Staffing Challenges and Burnout in Healthcare

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

Secondary Sidebar

Footer

Company

  • About Us
  • Advertise with Us
  • Reprints and Permissions
  • Op-Ed Submission Guidelines
  • 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 |