HealthPNX
Subscription-based with a flat fee per scan.
Regulatory Status Disclosed
Overview
HealthPNX is an artificial intelligence (AI) tool developed by Zebra Medical Vision designed to assist in the clinical assessment of adult chest X-ray cases for findings suggestive of pneumothorax. [1, 13]
- For: Radiologists and healthcare providers in care settings utilizing chest X-rays. [2, 6]
- Workflow Integration: HealthPNX integrates into existing radiology workflows by analyzing chest X-rays and flagging scans with suspected pneumothorax. [2, 3, 4] This allows for worklist prioritization within Picture Archiving and Communication Systems (PACS) or workstations, enabling radiologists to address urgent cases more rapidly. [3, 4, 13] The system can send alerts to a PACS/workstation for prioritization or triage. [12, 13]
- Capabilities: The AI network was trained using a large dataset of images to identify common clinical findings. [1, 2, 5] It automatically detects findings suggestive of pneumothorax based on chest X-ray or digital radiography scans. [1, 3, 4, 5] HealthPNX is a software workflow tool intended to aid in the prioritization and triage of radiological medical images. [12, 13]
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered pneumothorax detection on chest X-rays
- Automated alerts for urgent findings
- Integration with PACS/workstation for worklist prioritization
- Reduces turnaround time for diagnosis
- Increases radiologist confidence in diagnosis
- Provides passive notifications without modifying original images
- Trained on millions of images to identify over 40 common clinical findings
- AI-generated probability scores for clinical decision support
- Multi-modality AI analysis (part of Zebra's broader platform)
- Audit Trail & Compliance
Use Cases
- Prioritization and triage of radiological medical images
- Aiding in the clinical assessment of adult Chest X-Ray cases with features suggestive of Pneumothorax
- Reducing diagnostic interpretation time per case
- Improving early disease detection rates
- Increasing radiologist efficiency and case throughput
- Supporting preventative treatment pathways by identifying at-risk patients
What Physicians Need to Know
Evidence Base
HealthPNX's AI algorithm was trained on millions of images to identify over 40 common clinical findings. It received FDA 510(k) clearance in May 2019, marking it as the first AI chest X-ray triage product approved by the FDA. The underlying research demonstrated high rates of agreement between the algorithm and human radiologist experts.
Clinical Validation Studies
A pivotal performance study in the USA, using a retrospective cohort of 588 anonymized chest X-ray cases (146 positive for pneumothorax, 442 negative), validated HealthPNX's performance. The detection accuracy met the a-priori goal of over 80% compared to ground truth, established by three US Board Certified Radiologists. The device achieved an Area Under the Curve (AUC) of 98.3% (95% CI: [97.40%, 99.02%]) and an overall agreement of 93.03% (95% CI: [90.66%, 94.95%]) with ground truth. Sensitivity and specificity were 93.15% and 92.99%, respectively. The study also showed a statistically significant reduction in triage time, from a mean of 68.98 minutes to 8.05 minutes with HealthPNX.
Alert Fatigue Management
HealthPNX provides passive notifications on PACS worklists, aiming to prioritize urgent cases and reduce triage time. By flagging scans with suspected pneumothorax, it helps radiologists address critical conditions in a timely manner, thereby focusing attention on high-priority cases.
Override Rate Data
Specific override rate data for HealthPNX is not explicitly available in the provided information.
Differential Diagnosis Support
HealthPNX is designed to analyze chest X-rays for signs of pneumothorax and prioritize these cases for radiologist review. It is not intended for stand-alone clinical decision-making, to rule out pneumothorax, or to direct attention to specific image anomalies, focusing instead on triage and prioritization rather than broad differential diagnosis.
Guideline Update Frequency
While the AI algorithm was trained on millions of images, specific information regarding the frequency of guideline or algorithm updates for HealthPNX is not explicitly detailed. AI models typically undergo continuous improvement and retraining based on new data and performance monitoring.
Clinical Workflow Integration
HealthPNX integrates seamlessly into existing radiology workflows, providing passive notifications on PACS worklists without modifying original images. It automatically retrieves and processes chest X-ray studies, validates input data, and then analyzes images for suspected pneumothorax, making case-level output available for worklist prioritization. The system also provides error codes for study failures, allowing for earlier review.
Decision Audit Trail
During a clinical pilot study, all AI results and corrections made by radiologists were successfully stored in a database for downstream use. A dashboard allowed real-time monitoring of the AI system's performance, suggesting a robust audit trail for AI decisions and user interactions.
Physician Tip
Leverage HealthPNX as a critical triage tool to prioritize chest X-rays for suspected pneumothorax, significantly reducing turnaround time for urgent cases. While the AI provides high accuracy in flagging potential findings, always integrate its passive notifications into your comprehensive clinical assessment and do not use it as a standalone diagnostic tool. Familiarize yourself with how the system integrates into your PACS worklist for optimal efficiency.
HealthPNX is designed for seamless integration into existing radiology workflows and PACS/workstation systems, providing passive notifications directly within the radiologist's worklist. It supports data standards such as FHIR, HL7 v2, DICOM, SNOMED, and ICD-10, and is available for SaaS, on-premise, or hybrid deployment models. The system is compatible with Electronic Health Records (EHR systems) and does not modify original images.
Details
| Category | Clinical Decision Support & Reference, Radiology & Imaging AI |
| Pricing | Subscription-based with a flat fee per scan. — $1 per scan (for the AI1 solution, which includes HealthPNX and other algorithms) |
| Deployment | Cloud, On-premise, Hybrid |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated HealthPNX received FDA 510(k) clearance (K190362) on May 6, 2019, as a radiological computer-assisted triage and notification software system for pneumothorax detection in chest X-rays. It was the world's first AI chest X-ray triage product to receive FDA clearance. |
| Integrations | |
| EHR | Not specified |
| Specialties | Critical Care, Emergency Medicine, Radiology |
What the Web Says
HealthPNX, developed by Zebra Medical Vision, is an AI-powered alert system for pneumothorax (collapsed lung) detected in chest X-rays. It received FDA 510(k) clearance in May 2019. The technology aims to significantly reduce the time it takes for radiologists to identify urgent cases of pneumothorax and increase diagnostic confidence, potentially saving lives and improving patient outcomes.
Overall: PositiveStrengths
- Reduces turnaround time for diagnosing pneumothorax by over 80% compared to traditional methods.
- Increases radiologist confidence in diagnosing pneumothorax.
- First-of-its-kind FDA-cleared AI solution for chest X-ray triage.
- Automatically detects findings suggestive of pneumothorax and alerts medical teams.
- Trained using millions of images to identify over 40 common clinical findings.
Limitations
- Information regarding specific cons from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra is not readily available in the provided search results.
- Limited information on user experience beyond initial clinical validation studies.
- No recent reviews (post-2019) were found in the search results.
- The search results do not contain information about pricing or integration challenges.
- No direct feedback from Reddit, G2, or Capterra was found for HealthPNX.
- The LEDGR review for Zebra Medical Vision (the parent company) gives an overall score of 7.8/10, suggesting some areas for improvement, though specific cons for HealthPNX are not detailed.
Based on reviews from: Imaging Technology News, Health Data Management, Zebra Medical Vision Press Release, TheLEDGR
Last updated: 2026-07-21
Ratings & Reviews
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Press & Coverage
PR Newswire
Zebra Medical Vision Receives FDA Approval for World's First AI Chest X-ray Triage Product
Zebra Medical Vision announced FDA 510(k) clearance for HealthPNX, an AI alert for pneumothorax based on chest X-rays, aiming to reduce turnaround time and increase radiologist confidence in diagnosis. This marks the world's first AI chest X-ray triage product to receive such approval.
2019-05
Imaging Technology News
FDA Approves Zebra Medical Vision's HealthPNX AI Chest X-ray Triage Product
Zebra Medical Vision received FDA 510(k) clearance for HealthPNX, an AI-powered alert for pneumothorax on chest X-rays, designed to significantly reduce diagnosis turnaround time and improve radiologist confidence. The technology can save physicians over 80% of the time to reach an acute condition compared to traditional methods.
2019-05
Health Data Management
Zebra Medical AI tool helps diagnose pneumothorax quicker - Health Data Management
The FDA has cleared HealthPNX, an AI tool by Zebra Medical Vision, for clinical use to scan chest X-rays for pneumothorax, a dangerous lung condition. This clearance allows for urgent findings, potentially reducing turnaround times and increasing diagnostic confidence.
2019-05
Applied Radiology
FDA clears AI chest X-ray triage software from Zebra Medical Vision | Applied Radiology
HealthPNX, an AI alert for pneumothorax based on digital chest radiographs, received FDA 510(k) clearance in May 2019. Zebra Medical Vision anticipates this will reduce turnaround time for radiologists and increase confidence in diagnosing this difficult condition.
2019-05
NoCamels
Zebra Medical Gets FDA Nod For 1st AI-Powered Chest Scan Alert - NoCamels
Israel's Zebra Medical Vision received FDA 510(k) clearance for HealthPNX, an AI-powered alert system for pneumothorax based on chest X-rays. The system automatically detects findings suggestive of a collapsed lung and alerts medical teams.
2019-05
MassDevice
Zebra Medical wins FDA nod for AI-powered pneumothorax image analysis system
Zebra Medical Vision secured FDA 510(k) clearance for its HealthPNX AI-powered pneumothorax alerting system for chest X-rays. The company estimates the system could save physicians over 80% of the time needed to reach an acute condition diagnosis.
2019-05
NoCamels
Zebra Medical Gets FDA Clearance For AI-Powered Brain Bleed Alert - NoCamels
Zebra Medical Vision received its third FDA 510(k) clearance for HealthICH, an AI algorithm for intracranial hemorrhage, which, along with HealthPNX, is part of Zebra's Multi-Modality AI Triage Solution. These solutions aim to leverage AI in acute situations to prioritize cases.
2019-06
PR Newswire
Third FDA Clearance for Zebra-Med's AI Solution for Brain Bleeds Alerts - PR Newswire
Zebra Medical Vision announced its third FDA 510(k) clearance for HealthICH (intracranial hemorrhage), following HealthPNX (pneumothorax) in May 2019. HealthPNX was noted as the world's first AI chest X-ray triage product.
2019-06
Videos
Product demos, reviews, and walkthroughs for HealthPNX.
No videos found. Search YouTube directly
Frequently Asked Questions
HealthPNX is designed to integrate into existing clinical workflows, particularly within radiology, by making case-level output available to a PACS/workstation for worklist prioritization or triage. It functions as a software workflow tool that flags scans for urgent review, aiming to reduce turnaround time. The integration typically involves connecting with your EMR and existing imaging systems, and while specific learning curve details aren't provided, effective CDS integration generally requires organizational and workflow alignment, along with just-in-time education and cognitive support.
HealthPNX has received U.S. Food and Drug Administration (FDA) 510(k) clearance as an AI alert for pneumothorax based on chest X-rays. It has been evaluated and verified in accordance with software specifications and applicable performance standards through Software Development and Validation & Verification processes, ensuring compliance with federal regulations and guidance documents for software in medical devices. While HIPAA is crucial for data privacy in healthcare, the search results specifically highlight FDA clearance for HealthPNX as a medical device.
HealthPNX differentiates itself as an AI-powered triage tool specifically for detecting pneumothorax on chest X-rays, aiming to reduce turnaround time for urgent findings. Its evidence base includes a pivotal performance study with a retrospective cohort of anonymized Chest X-Ray cases, demonstrating high agreement with ground truth and a statistically significant reduction in triage time compared to standard care. Other CDS systems may offer broader functionalities or focus on different clinical areas, but HealthPNX's strength lies in its specialized AI for radiological image prioritization.
While specific pricing for HealthPNX is not detailed in the search results, similar health IT solutions often utilize subscription-based models, billed annually per provider or based on volume. These models typically include an initial implementation fee covering training, setup, and technical integration. Ongoing expenses usually involve subscription or support fees, with some models offering lower costs for longer commitments or minimum annual volumes.
HealthPNX is specifically designed to aid in the prioritization and triage of radiological medical images for suspected pneumothorax and is not intended for standalone clinical decision-making or to rule out pneumothorax. While it aims to reduce triage time, a general limitation of clinical decision support systems is the potential for alert fatigue if alerts are excessive or poorly targeted, leading clinicians to become desensitized. The system relies on chest X-ray data inputs and its current scope is focused on pneumothorax detection.
HealthPNX's recommendations and alerts are supported by its FDA 510(k) clearance, which is based on a pivotal performance study. This study involved a retrospective cohort of 588 anonymized Chest X-Ray cases, demonstrating an overall agreement of 93.03% with ground truth, and sensitivity and specificity of approximately 93% for pneumothorax detection. The AI algorithm was trained on millions of images to identify findings suggestive of pneumothorax, and clinical validation studies have shown its potential to substantially reduce turnaround time and increase radiologist confidence.
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| Last Verified: 2026-04-19 | First Added: 2026-04-19