Viz SDH

by Viz.ai  · Based in United States → — AI-powered disease detection and intelligent care coordination
Emergency Medicine Neurosurgery Radiology

Subscription
Regulatory Status Disclosed

Overview

Viz SDH is an artificial intelligence (AI) powered tool developed by Viz.ai, designed for the automatic detection of subdural hemorrhage (SDH) in non-contrast CT images of the head. It identifies both acute and chronic subdural bleeds, enabling physicians to effectively triage patients and deliver optimal care. The system operates as a notification-only, parallel workflow tool, analyzing images and sending alerts to appropriate medical specialists, such as neurovascular specialists or neurosurgeons, independent of the standard of care workflow. This facilitates faster assessment and communication among care teams, aiming to improve patient outcomes by expediting diagnosis and treatment pathways for time-critical conditions.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automatic AI detection of acute and chronic subdural hemorrhage on non-contrast CT images.
  • Real-time notification to neurovascular or neurosurgical specialists.
  • Mobile application for receiving alerts and previewing images (for informational purposes).
  • Quantification of subdural collections, including volume, thickness, and midline shift (available with Viz SDH+ module).
  • Integration into existing clinical workflows (e.g., radiology workflow, mobile, web).
  • Supports image sharing and communication among care teams.

Use Cases

  • Expediting diagnosis and treatment pathways for subdural hematomas.
  • Improving care coordination and communication among multidisciplinary care teams.
  • Triage and prioritization of patients with suspected subdural hemorrhage.
  • Facilitating faster, more informed treatment decisions, especially for acute and chronic bleeds.
  • Optimizing emergency healthcare workflows and reducing time to treatment.
  • Supporting guideline-directed interventions for neurovascular diseases.

What Physicians Need to Know

Evidence Base
Viz SDH utilizes AI algorithms, specifically Convolutional Neural Networks (CNNs), to analyze non-contrast CT images for the detection and quantification of subdural hematomas. It is an FDA-cleared solution. The broader Viz Hemorrhage solution, which includes Viz SDH, combines AI-powered imaging analysis with automated measurements and care coordination.
Clinical Validation Studies
A multi-center trial involving over 500 patients demonstrated high accuracy for Viz SDH, achieving 94% sensitivity and 92% specificity in detecting subdural hemorrhages. An independent validation imaging data set showed the CNN performing exceptionally well with a sensitivity of 91.4%, specificity of 96.4%, and accuracy of 95.1%. The Viz Subdural Plus module, which received FDA 510(k) clearance, provides automated labeling and precise quantification of subdural collections, including volume, thickness, and midline shift.
Alert Fatigue Management
Providers using the Viz neuroimaging platform have the discretion to disable or limit alerts, which can help manage alert fatigue.
Differential Diagnosis Support
Viz SDH is designed to identify and differentiate between acute and chronic subdural hemorrhages, which is crucial for guiding distinct treatment pathways. It is a notification-only tool, not intended for broad diagnostic use beyond alerting to suspected findings.
Clinical Workflow Integration
Viz SDH operates as a notification-only, parallel workflow tool, seamlessly integrating with existing PACS, EHR, and cloud environments. It automatically analyzes non-contrast CT images and sends notifications to appropriate medical specialists, allowing for image preview via a HIPAA-compliant mobile application. This integration aims to streamline workflow, reduce manual effort, and increase efficiency in the diagnosis process.
Decision Audit Trail
Viz.ai has completed SOC 2 Type II + HIPAA audits for its platform, validating its focus on security, compliance, and responsible AI, ensuring effective controls for managing customer data.
Physician Tip

Leverage Viz SDH for rapid, AI-powered detection and quantification of both acute and chronic subdural hemorrhages from non-contrast CT scans to expedite specialist notification and care coordination. Utilize the mobile application for quick image review and communication with the care team, but always confirm findings on a diagnostic viewer before making definitive treatment decisions. Customize alert settings to minimize fatigue while ensuring critical notifications are received promptly. The automated measurements provided by Viz Subdural Plus can significantly aid in assessing severity and monitoring progression, especially for patients considered for interventions like MMA embolization.

Viz SDH is part of the Viz.ai One platform, designed for robust interoperability with existing hospital systems, including PACS and EHR. Its cloud-native architecture facilitates seamless data transfer and communication across the entire care network, enhancing system-wide collaboration. The platform is supported by Microsoft Cloud for Healthcare, ensuring secure and scalable deployment of AI-driven insights.

Details

Category Neurology AI, Radiology & Imaging AI, Triage & ER/ICU AI
Pricing Subscription
  • Annual fee based on the number of algorithms used and the size of the population served; enterprise (hospital/health system) contracts
DeploymentCloud-based; available on mobile, web, and within the radiology workflow.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Viz SDH received U.S. Food and Drug Administration (FDA) 510(k) clearance (K220439) on July 25, 2022. It is cleared as a radiological computer-assisted triage and notification software for detecting subdural hemorrhage.

Integrations
EHR Not specified
Specialties Emergency Medicine, Neurosurgery, Radiology

What the Web Says

Viz.ai's Subdural Hemorrhage (SDH) solution is an AI-powered platform designed to automatically detect acute and chronic subdural hemorrhages from CT scans, aiming to expedite diagnosis and treatment. It is widely adopted in hospitals and health systems, with physicians reporting it has fundamentally changed stroke and trauma workflows by providing faster notifications and facilitating care coordination.

Overall: Positive

Strengths

  • Rapid and accurate detection of subdural hemorrhages, including differentiation between acute and chronic types.
  • Significantly reduces time-to-treatment for time-critical conditions like stroke and pulmonary embolism.
  • Enhances care coordination by immediately alerting specialists and care teams.
  • Improves workflow efficiency for radiologists and other healthcare professionals.
  • High sensitivity and specificity in detecting intracranial hemorrhages on non-contrast brain CTs.
  • User-friendly interface and relatively smooth onboarding process for non-technical users.

Limitations

  • Enterprise-only pricing, making it inaccessible to individual physicians.
  • Not a general clinical decision support tool; specialized for imaging triage.
  • Occasional flagging of clinically insignificant findings (e.g., subsegmental PEs).
  • Some users reported issues with SSO and user management, requiring tweaks.
  • Vendor support, while responsive, has not always been timely.
  • Potential for false positives, though many are for significant findings that still benefit from expedited review.

Based on reviews from: Comparably, Clinical AI Report, FeaturedCustomers, Google Play, PMC (PubMed Central), Diagnostic Imaging, AuntMinnie, R&D World, Fierce Biotech, Medical Product Outsourcing, CREAITIQUE

Last updated: 2026-07-21

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Press & Coverage

AuntMinnie
Viz.ai receives FDA nod for brain AI software
Viz.ai received FDA 510(k) clearance for Viz SDH, an AI-powered software that detects subdural hemorrhage (SDH) to help physicians triage patients and deliver care more effectively. SDH is projected to become the most common neurosurgical diagnosis by 2031, and Viz SDH can identify both acute and chronic bleeds.
2022-07
NeuroNews International
Viz.ai receives US FDA 510(k) clearance for Viz SDH, announces Hyperfine...
Viz.ai announced FDA 510(k) clearance for Viz Subdural (SDH), an AI algorithm designed to automatically detect subdural hemorrhage. This clearance allows for effective patient triage and care delivery.
2022-07
AI Business
FDA approves AI diagnostic tool for brain hemorrhages
The FDA approved Viz Subdural (SDH), an AI tool from Viz.ai that automatically detects chronic and acute subdural hematomas on brain scans. This tool aims to speed up diagnosis and treatment, with clinical trials showing 94% sensitivity and 92% specificity.
2022-08
Viz.ai Press Release
Viz.ai Receives FDA 510(k) Clearance for Vizu2122 SUBDURAL (SDH)
Viz.ai announced FDA 510(k) clearance for Viz Subdural (SDH), an AI-powered platform for detecting subdural hemorrhage. It is designed to identify both acute and chronic bleeds and quickly notify care teams for timely intervention.
2022-07
Diagnostic Imaging
FDA Clears New AI Tool for Diagnosing Subdural Hemorrhage
Viz Subdural Hematoma (SDH) received 510(k) clearance from the FDA for its AI-powered algorithm that diagnoses subdural hemorrhages. The tool differentiates between acute and chronic bleeds, which is crucial for appropriate treatment pathways.
2022-07
Neurology Reviews
Special Report: 2022 Neurology Drug & Device Approvals
Viz SDH, a radiologic computer-assisted triage and notification software, was cleared by the FDA on July 25, 2022. This AI-powered software automatically detects subdural hemorrhage on neuroimaging studies with 94% sensitivity and 92% specificity.
2023-01
Journal of NeuroInterventional Surgery
An artificial intelligence (AI)-based approach to clinical trial recruitment: The impact of Viz RECRUIT on enrollment in the EMBOLISE trial
This study evaluated Viz RECRUIT SDH, an AI-based software that detects SDH in CT images, for its impact on enrollment in the EMBOLISE trial. The implementation of Viz RECRUIT SDH increased patient enrollment by 36% and demonstrated an 81.4% positive predictive value.
2023-06
Business Wire
Viz.ai Debuts Viz ANX, the First AI-powered Cerebral Aneurysm Detection Solution at SVIN 2021
Viz.ai introduced Viz SDH as a research-only algorithm supporting the EMBOLISE trial, designed to detect suspected subdural hematoma and alert clinicians to potential study candidates. This was announced alongside Viz ANX, an AI-powered cerebral aneurysm detection platform.
2021-11

Videos

Product demos, reviews, and walkthroughs for Viz SDH.

View all on YouTube

Frequently Asked Questions

Viz SDH is an AI-powered, notification-only tool that analyzes non-contrast CT images of the head for suspected subdural hemorrhage (SDH) in parallel to standard image interpretation. Upon detection, it sends notifications to appropriate specialists, such as neurovascular specialists or neurosurgeons, to expedite review and care coordination.
Viz SDH has received FDA 510(k) clearance for automatically detecting acute and chronic subdural hemorrhage. It is a notification-only tool and not intended for diagnostic use beyond alerting specialists; clinicians are responsible for viewing non-compressed images on a diagnostic viewer and making care decisions.
Yes, while Viz SDH is a prominent AI solution, other AI-based computer-aided triage tools exist for intracranial hemorrhage detection, such as Aidoc and RapidAI. Traditional methods involve manual interpretation of non-contrast CT scans by radiologists and other clinicians, which can be time-consuming.
Viz.ai generally offers enterprise-level pricing for its platform, including modules like Viz SDH, for hospitals and health systems. The Viz Platform, which includes Viz SDH, is clinically validated and reimbursed by Medicare, demonstrating its recognized value in improving patient outcomes and access to care.
Viz SDH is a parallel workflow tool and should not be used in lieu of a full patient evaluation or relied upon to make or confirm a diagnosis. Notified clinicians must view non-compressed images on a diagnostic viewer and engage in appropriate patient evaluation before making care-related decisions.
In a multi-center trial of over 500 patients, the Viz SDH AI algorithm achieved a sensitivity of 94% and specificity of 92% in detecting subdural hemorrhages. The Viz Subdural Plus module further enhances this by providing automated measurements of volume, thickness, and midline shift, with high accuracy.
Viz SDH aims to improve outcomes by automatically detecting subdural hemorrhages and expediting communication and image sharing to the care team, enabling faster triage and intervention. This rapid notification is crucial for both acute and chronic subdural bleeds, allowing for more timely and effective treatment pathways.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19

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