Radify Triage

by Envisionit Deep AI  · Based in United Kingdom → — AI Monitoring and Assurance Platform
Critical Care Emergency Medicine Radiology

Regulatory Status Disclosed

Overview

Radify Triage by Envisionit DeepAI is an artificial intelligence-powered software designed to analyze adult chest X-rays to assist in clinical decision support and workflow prioritization.

The tool is primarily built for radiologists, emergency medicine physicians, and intensive care clinicians operating in high-volume or time-critical settings, such as emergency departments, intensive care units, and public health clinics. It is designed to identify and highlight critical pathologies, specifically triaging conditions like pneumothorax and pleural effusion, as well as detecting signs associated with pneumonia and tuberculosis.

In terms of clinical workflow integration, Radify Triage operates in the background, processing medical imaging data directly from PACS or RIS systems. It provides case-level outputs and alerts directly within the radiologist’s existing worklist, allowing clinicians to prioritize urgent scans and reduce the time to treatment for critical cases without requiring additional manual steps or clicks.

  • Automated Prioritization: Automatically flags and escalates critical chest X-ray findings to the top of the reading queue.
  • Pathology Detection: Identifies and highlights key thoracic abnormalities, including pneumothorax, pleural effusion, and infectious disease indicators.
  • Seamless Integration: Works autonomously with existing PACS/RIS infrastructures to support point-of-care diagnostics and high-throughput screening environments.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-assisted chest X-ray analysis
  • Triage and prioritization of critical findings (pneumothorax, pleural effusion)
  • Rapid analysis (average of three seconds to alert)
  • High accuracy in triaging pathologies
  • Provides case-level output for PACS worklist prioritization
  • Enhances efficiency in emergency rooms and ICUs
  • Integrates into existing PACS/RIS workflows
  • Supports cloud, on-premise, or hybrid deployment

Use Cases

  • Prioritizing urgent chest X-rays in emergency rooms
  • Prioritizing urgent chest X-rays in intensive care units
  • Assisting medical professionals in rapid diagnosis and treatment
  • Improving workflow efficiency in radiology departments
  • Addressing radiologist scarcity by automating triage

What Physicians Need to Know

DICOM Support & Standards
RADIFY® Triage receives frontal (AP/PA) chest X-rays in DICOM format from PACS.
PACS Integration Method
RADIFY® Triage provides case-level output to the PACS worklist for prioritization. RATIFY integrates seamlessly into existing PACS, RIS, and AI platforms through secure APIs.
Reading Room Workflow Impact
RADIFY® Triage is designed to assist radiologists in efficiently and accurately identifying abnormalities, prioritizing urgent cases. It can label and prioritize over 2000 x-rays per minute. The system aims to enhance the efficiency and effectiveness of medical professionals in emergency rooms and intensive care units by aiding in the triage process and delivering rapid, accurate prioritization of radiology images. AI-triaged worklists can significantly reduce report generation time and overall turnaround time for chest radiographs.
AI Model Architecture (deep learning approach)
RADIFY® Triage uses an AI algorithm based on Deep Convolutional Neural Networks (DCNN) to analyze images for features suggestive of pneumothorax or pleural effusion. The solution leverages machine learning and the expertise of radiologists to recognize patterns in imaging.
Processing Speed (per study)
RADIFY® Triage can label and prioritize over 2000 x-rays per minute. It takes an average of three seconds to alert healthcare professionals.
FDA Clearance Pathway (510k/De Novo)
Envisionit Deep AI has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Radify. It was cleared for triaging pneumothorax and pleural effusion. The device is classified as Radiological Computer-Assisted Prioritization Software For Lesions (Product Code: QFM).
Supported Modalities (CT/MRI/X-ray/US)
RADIFY® Triage analyzes adult chest X-ray images. Envisionit Deep AI also has other RADIFY products for mammograms and ultrasound.
Sensitivity & Specificity Data
For pneumothorax, the AUC was 97.43 (95% Cl: [97.12, 97.74]), Sensitivity 94.81% (95% Cl: [93.90, 95.73]) and Specificity 97.91% (95% Cl: [97.00, 98.83]). The results for pneumothorax were consistent in both genders and across a wide range of ages.
RSNA/ACR Validation
Envisionit Deep AI utilizes its proprietary RATify platform for validation and quality assurance, including diverse data and subgroup analysis. RATIFY provides post-market surveillance and continuous monitoring for AI, generating evidence for validation studies, clinical trials, and regulatory filings.
Physician Tip

RADIFY® Triage can significantly improve workflow efficiency by prioritizing urgent chest X-ray cases, especially in high-volume settings like emergency rooms and ICUs. While the AI provides rapid analysis and triage, it's crucial to remember that it is a clinical decision support tool and not intended for standalone diagnostic decision-making. The tool's high sensitivity and specificity for pneumothorax and pleural effusion on chest X-rays can aid in early detection and intervention. The system's ability to label and prioritize a large number of X-rays per minute can help manage case overload and reduce turnaround times.

RADIFY® Triage integrates with existing PACS systems by receiving DICOM images and providing case-level output to the PACS worklist for prioritization. The broader RATIFY platform seamlessly integrates into existing PACS, RIS, and AI platforms through secure APIs, monitoring model outputs in real-time without disrupting current clinical workflows.

Details

Category Radiology & Imaging AI, Triage & ER/ICU AI
Pricing Unknown
DeploymentIntegrates directly into existing PACS/RIS workflows.
API AvailableUnknown
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Cleared AI-estimated
GDPR Yes AI-estimated
Integrations
EHR Not specified
Specialties Critical Care, Emergency Medicine, Radiology

What the Web Says

Radify Triage by Envisionit Deep AI is an AI-assisted chest X-ray system that received FDA 510(k) clearance in January 2024 for triaging pneumothorax and pleural effusion. The system is designed to enhance the efficiency of medical professionals in emergency rooms and intensive care units by providing rapid and accurate prioritization of radiology images. It operates as a software-only device, integrating with existing PACS worklists to passively triage adult frontal chest X-rays.

Overall: Positive

Strengths

  • FDA 510(k) cleared for triaging pneumothorax and pleural effusion.
  • High accuracy in triaging both pathologies.
  • Averages three seconds to alert healthcare professionals.
  • Evaluated using diverse data and subgroup analysis to mitigate bias and ensure applicability across diverse demographics.
  • Enhances efficiency and effectiveness of medical professionals in emergency rooms and intensive care units.
  • Software-only device that integrates with PACS worklists.

Limitations

  • No specific cons were identified in the provided search results.
  • Limited information available from independent tech reviewers, Reddit, G2, or Capterra.
  • While performance metrics are provided, real-world generalizability across diverse clinical settings is a common concern for cleared AI devices.

Based on reviews from: auntminnie.com, parse.gl, hardianhealth.com, tracxn.com, blackfordanalysis.com, medtekki.no, innolitics.com, healthcareaiops.com, researchgate.net, parikhradiology.com, nih.gov, braid.health, healthaidb.com

Last updated: 2026-10-29

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Press & Coverage

fda.gov
Radify Triage FDA 510(k) Clearance
Envisionit Deep AI Ltd. received FDA 510(k) clearance for Radify Triage on January 17, 2024, under product code QFM, classifying it as a Class II radiological computer-aided triage and notification software.
2024-01
auntminnie.com
Envisionit receives FDA clearance for Radify system
Envisionit Deep AI announced on January 25, 2024, that its AI-assisted chest x-ray system, Radify, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for triaging pneumothorax and pleural effusion. The company highlighted the system's high accuracy and speed, averaging three seconds to alert healthcare professionals.
2024-01
hardianhealth.com
Envisionit Deep AI Becomes First African-Founded Company to Receive FDA Clearance for an AI Device
With support from Hardian Health, Envisionit Deep AI became the first African-founded company to receive FDA 510(k) clearance for an AI device, specifically for its assisted radiology solution, RADIFY® AI, to triage Pneumothorax and Pleural Effusion.
2024-03
innolitics.com
How to Get Your AI-Generated, Vibe-Coded Medical Device FDA-Cleared
Radify Triage, developed by Envisionit Deep AI Ltd., is mentioned as a software that provides case-level output for worklist prioritization or triage through the PACS interface, rather than having its own distinct user interface for result presentation.
2025-05
innolitics.com
What Your First 510(k) Actually Costs You
Radify Triage by Envisionit Deep AI Ltd. is cited in the context of ground truth establishment for AI/ML medical devices, noting that its ground truth was established by three board-certified ABR (USA) radiologists with a minimum of 11 years of experience.
2025-09
healthcareaiops.com
FDA 510(k) K231871: Radify Triage by Envisionit Deepai, Ltd.
Radify Triage by Envisionit Deepai, Ltd. received FDA 510(k) clearance on January 17, 2024, under the AI-associated product code QFM.
2026-08
nih.gov
AI-powered medical devices for respiratory disease detection and diagnostics: A comprehensive review
Radify Triage from Envisionit DeepAI Ltd. is listed among FDA-approved AI-powered medical devices for detecting pleural effusion and pneumothorax from chest X-rays, with its clearance date noted as January 17, 2024.
2024-01
liners.com
Radify AI - AI Medical Imaging Tool
RADIFY AI is an AI-powered medical imaging tool that detects and triages abnormalities on chest X-rays, including TB-associated patterns and pneumonia-related pathologies, processing over 2000 X-rays per minute and categorizing cases by probability.
2026-10

Videos

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Frequently Asked Questions

Radify Triage is an AI-powered software designed to analyze adult chest X-ray images for critical findings such as pleural effusion and pneumothorax. It integrates with PACS to provide case-level notifications, helping radiologists prioritize urgent cases for review without removing them from the queue.
Radify Triage helps improve workflow efficiency and patient care by flagging suspicious cases for prioritization. It aims to reduce turnaround times for critical findings, allowing for quicker communication and potentially earlier treatment.
Yes, Radify Triage by Envisionit Deepai, Ltd. received FDA 510(k) clearance on January 17, 2024, under product code QFM. Clinical validation showed high accuracy in detecting pneumothorax and pleural effusion on chest X-rays with an AUC > 0.95, sensitivity > 94%, and specificity > 96%.
Radify Triage integrates with PACS to flag images for prioritization, providing a passive notification for worklist triage within a standard care workflow. It does not mark images or remove cases from the queue.
Radify Triage acts as a triage tool to flag suspicious cases but does not replace clinical decision-making. While AI can significantly reduce turnaround times during high workload periods, its impact may be minimal during off-hours. The technology cannot completely replace the human element, and clinical validation by a radiologist remains essential.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-18 | First Added: 2026-04-18
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