Viz ANEURYSM
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Regulatory Status Disclosed
Overview
Viz ANEURYSM (also known as Viz ANX) is an artificial intelligence-powered radiological computer-assisted triage and notification software device developed by Viz.ai. It is designed for the analysis of CT images of the head to auto-detect suspected cerebral aneurysms. The tool assists hospital networks and trained radiologists by flagging and prioritizing studies with suspected aneurysms during routine patient care, aiming to ensure appropriate monitoring and treatment.
The platform includes Viz 3D CTA, which offers AI-enhanced 3D imaging for clear views of neurovasculature, interactive tools for better assessment of vessels, and streamlined workflows through automated 3D processing. Viz ANEURYSM facilitates secure, HIPAA-compliant communication among care teams, allowing for rapid coordination and one-click referrals for follow-up, thereby improving patient outcomes and care pathways.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Auto-detection of suspected cerebral aneurysms in CTAs
- AI-enhanced 3D imaging (Viz 3D CTA)
- Interactive tools for neurovascular assessment
- Streamlined workflow and automated 3D processing
- Real-time notification to appropriate care providers
- HIPAA-compliant secure messaging for care team coordination
- One-click referral activation for follow-up
- High sensitivity and specificity for aneurysm detection (e.g., u2265 4mm aneurysms)
- Integration into Viz Intelligent Care Coordination Platform
- Study list prioritization and triage
Use Cases
- Early detection of cerebral aneurysms
- Workflow triage and prioritization of CTA studies
- Enhanced care coordination for neurovascular patients
- Facilitating timely referrals for follow-up and treatment
- Improving patient outcomes by preventing aneurysm rupture
- Population health tool for enhanced care management
What Physicians Need to Know
Evidence Base
Viz ANEURYSM utilizes artificial intelligence (AI) and machine learning (ML) algorithms to analyze Computed Tomography Angiography (CTA) images for the detection of suspected cerebral aneurysms and abdominal aortic aneurysms (AAAs). The literature scope includes retrospective evaluations of CTA exams.
Clinical Validation Studies
Multiple studies support Viz ANEURYSM's performance. One study on 703 head CTA exams demonstrated a sensitivity of 96.6% and specificity of 98.1% for cerebral aneurysm detection, with a positive predictive value (PPV) of 82.4% and a negative predictive value (NPV) of 99.7%. It effectively detected multiple aneurysms and those smaller than 4mm. Another evaluation across 963 head CT scans showed a specificity of 96.8% and an NPV of 97.2%. A study involving 528 CTAs with 674 aneurysms reported 94% accuracy. For aneurysms u22654mm, a study found sensitivity of 93.8%, specificity of 94.2%, and PPV of 88.2%. Notably, a study screening nearly 1,200 CTAs revealed that 85% of aneurysms identified by Viz ANEURYSM had not been previously referred for follow-up.
Alert Fatigue Management
The Viz.ai platform, which includes Viz ANEURYSM, allows providers to disable or limit alerts at their discretion, offering a mechanism to manage potential alert fatigue.
Drug Interaction Checking
As an AI-powered imaging analysis and care coordination tool for aneurysm detection, drug interaction checking is not an applicable feature.
Differential Diagnosis Support
Viz ANEURYSM primarily focuses on the detection and triage of suspected cerebral and abdominal aortic aneurysms from CTA images, rather than providing broad differential diagnosis support across various neurological or vascular conditions. It aids in identifying aneurysms that might otherwise be missed.
Clinical Workflow Integration
Viz ANEURYSM is designed to streamline clinical workflows by automating 3D processing of images and notifying appropriate care providers of suspected aneurysms. It integrates with existing hospital systems, including Electronic Health Records (EHR), to provide concise, actionable summaries of patient information. The platform facilitates HIPAA-compliant communication among care teams, even across different hospitals, and enables one-click referrals for follow-up, aiming to prevent patients from being lost to follow-up.
Decision Audit Trail
The platform offers traceability of information to its source and allows for tracking the patient journey, including aneurysm size, location, and relevant history. This functionality supports an implicit decision audit trail.
Physician Tip
Viz ANEURYSM is a powerful AI tool for early detection and triage of cerebral and abdominal aortic aneurysms, potentially reducing missed diagnoses and improving time to treatment. Leverage its automated notifications and integrated communication features for rapid care team coordination. While highly accurate, remember it's a decision support tool; clinical judgment and full patient evaluation remain paramount. Utilize the 3D imaging and patient journey tracking for comprehensive assessment and follow-up planning, especially for smaller aneurysms that might require surveillance.
Viz ANEURYSM seamlessly integrates with existing hospital workflows and imaging systems (e.g., CTAs). It connects with EHRs to summarize patient data and supports HIPAA-compliant communication within care teams and across health systems. Partnerships, such as with Illuminate, further enhance its ability to identify and monitor at-risk patients for long-term follow-up and disease management.
Details
| Category | Neurology AI, Radiology & Imaging AI |
| Pricing | Contact for pricing — Subscription-based; Enterprise (Hospital/Health System) |
| Deployment | Cloud-based; Standalone application; Mobile software module |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated Viz ANEURYSM (Viz ANX) received U.S. FDA 510(k) clearance (K213319) on February 18, 2022. It is cleared as a radiological computer-assisted triage and notification software device for analysis of CT images of the head to flag and prioritize studies with suspected aneurysms. |
| Integrations | |
| EHR | Not specified |
| Specialties | Neurology, Neurosurgery, Radiology |
What the Web Says
Viz ANEURYSM is an AI-powered platform designed to detect suspected cerebral aneurysms from CTA scans and facilitate timely referrals and care coordination. Studies have shown its high accuracy in identifying aneurysms, including those that may have been previously missed, and its potential to improve workflow efficiency and patient outcomes. The platform also offers AI-enhanced 3D imaging and secure communication tools for care teams.
Overall: PositiveStrengths
- High sensitivity and specificity in aneurysm detection, even for smaller aneurysms (>=4mm).
- Identifies aneurysms that may have been missed in routine clinical care.
- Automates 3D processing of images, saving time and improving workflow efficiency.
- Facilitates rapid referrals and care coordination among specialists, even across different hospitals.
- Provides AI-enhanced 3D imaging for clearer visualization of neurovasculature.
- HIPAA-compliant secure communication tools for care teams.
Limitations
- Some Reddit users express general anxiety and fear about living with an aneurysm diagnosis, regardless of detection method.
- The standalone application's images are for informational purposes only and not for diagnostic use.
- Limited to detecting aneurysms at least 4mm in diameter.
- One physician noted occasional flagging of clinically insignificant subsegmental PEs by Viz's PE detection (a related product), suggesting a potential for similar issues with aneurysm detection.
- Initial false alarms during early testing required recalibration of the algorithm.
- The cost to hospitals can range from $50,000 to over $1 million annually depending on hospital size and targeted diseases.
Based on reviews from: Business Wire, Viz.ai, Fierce Biotech, NeuroNews, Forbes, Clinical AI Report, AuntMinnie, Vascular News, PubMed, Journal of NeuroInterventional Surgery, Reddit, G2
Last updated: 2026-07-21
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Press & Coverage
Viz.ai
Viz.ai Receives FDA 510(k) Clearance for Vizu2122 ANEURYSM (ANX)
Viz.ai announced it received FDA 510(k) clearance for Viz ANEURYSM, an AI-powered algorithm designed to detect suspected cerebral aneurysms and standardize workflow across health systems. This aims to improve patient follow-up care and outcomes for aneurysm patients.
2022-03
Diagnostic Imaging
AI-Powered Algorithm Gets FDA 501(k) Clearance for Detection of Subarachnoid Hemorrhages | Diagnostic Imaging
Viz ANEURYSM, an AI-powered algorithm, received FDA 510(k) clearance to improve the diagnosis of subarachnoid hemorrhages and facilitate timely intervention. A 2020 study at the University of Toronto showed a 94% accuracy rate for the algorithm in detecting aneurysms on CTA scans.
2022-02
BioSpace
New Study Finds 85% of Aneurysms Identified by Vizu2122 ANEURYSM had not Been Referred for Neurovascular Review - BioSpace
Viz.ai presented new data at SVIN demonstrating that 85% of aneurysms detected by Viz ANEURYSM across eight stroke centers in Texas had not been previously referred for follow-up. This highlights the algorithm's impact on automated detection and facilitating referrals for unruptured cerebral aneurysms.
2022-11
BioSpace
Viz.ai Announces Six Clinical Studies that Further Validate Impact of Vizu2122 Neuro Suite on Patient Care - BioSpace
Viz.ai announced new clinical data from six studies presented at ISC 2024, showing positive real-world impact of Viz.ai's Neuro Suite, including Viz Aneurysm, on various neurology pathologies. One study found Viz Aneurysm demonstrated 96.8% specificity and 97.2% negative predictive value in detecting aneurysms across 963 CT scans.
2024-02
Vascular News
New studies support use of Viz.ai's solutions for detecting suspected cerebral aneurysms and AAAs - Vascular News
Two studies presented at RSNA 2024 demonstrated the effectiveness of Viz Aneurysm and Viz AAA in detecting suspected cerebral and abdominal aortic aneurysms. Viz Aneurysm showed a sensitivity of 96.6% and specificity of 98.1% in a retrospective evaluation of 703 head CTA exams.
2024-11
Viz.ai
Viz.ai and Illuminate Expand Partnership to Improve Cerebral Aneurysm Patient Care
Viz.ai expanded its partnership with Softek Illuminate, Inc. to improve cerebral aneurysm patient care by combining Viz Aneurysm's AI detection with Illuminate's Discovery360 for identifying and monitoring at-risk patients. This collaboration aims to ensure timely diagnosis and follow-up, preventing patients from being lost to care.
2025-01
Stroke: Vascular and Interventional Neurology
Machine Learningu2013Enabled Detection of Unruptured Cerebral Aneurysms Improves Detection Rates and Clinical Care | Stroke: Vascular and Interventional Neurology
This peer-reviewed article discusses how Viz ANEURYSM, an AI-based UIA detection software, improved detection rates and clinical care for unruptured cerebral aneurysms. The study found that 10 out of 36 (27.8%) true aneurysms flagged by Viz ANEURYSM were missed by physicians interpreting the CTAs.
2023-09
Stroke
Abstract TP10: Artificial Intelligence Algorithm as a Diagnostic Tool for Aneurysms | Stroke
This abstract from the American Heart Association's journal 'Stroke' presents a study evaluating Viz Aneurysm as a diagnostic tool. It found that the algorithm performed well in flagging scans with definite aneurysms, with a specificity of 96.78% and a negative predictive value of 97.23%.
2024-02
Videos
Product demos, reviews, and walkthroughs for Viz ANEURYSM.
Express Webinar: The Latest Vizu2122 ANEURYSM Data
Frequently Asked Questions
Viz ANEURYSM integrates into existing hospital workflows by automatically analyzing CT angiography (CTA) scans for suspected aneurysms and prioritizing studies for rapid review. It notifies appropriate care providers via mobile, web, and within the radiology workflow, facilitating HIPAA-compliant communication among multidisciplinary teams. This streamlined process can lead to 73% faster CTA-to-team notifications and helps ensure patients are not lost to follow-up.
Viz ANEURYSM is a computer-assisted triage and notification tool, intended to assist with workflow prioritization and not for standalone diagnostic use; radiologists remain responsible for final diagnostic decisions. It is generally limited to detecting cerebral aneurysms at least 4mm in diameter, although some studies have noted detection of smaller aneurysms. While demonstrating high sensitivity and specificity in studies, its positive predictive value has varied across different evaluations.
Viz ANEURYSM ensures patient data privacy and security through comprehensive programs aligned with leading international standards. Viz.ai is SOC 2 Type II and HIPAA compliant, and also holds ISO 27001, ISO 27701, ISO 27799, ISO 27017/27018 certifications. The platform processes highly sensitive protected health information (PHI) across numerous hospitals in the U.S. and Europe with disciplined, continuously monitored controls.
Viz ANEURYSM is an FDA 510(k) cleared AI-powered solution for the detection and triage of suspected cerebral and abdominal aortic aneurysms. Key differentiators include its ability to automatically analyze CTAs, provide AI-enhanced 3D imaging with interactive tools, and streamline referrals to ensure timely follow-up. It also offers a HIPAA-compliant communication platform to connect multidisciplinary care teams across health systems.
Viz ANEURYSM operates on a subscription-based model, where hospitals pay an annual fee for its use. While specific pricing is not publicly disclosed, its cost-effectiveness is often evaluated by considering the potential for increased aneurysm detection, accelerated treatment decisions, and improved patient follow-up. Viz.ai provides an economic impact calculator to help institutions estimate potential revenue from additional treatments and follow-up consultations.
Viz ANEURYSM plays a crucial role in improving patient follow-up by automatically detecting suspected aneurysms and streamlining referrals to specialists. Studies indicate that a significant percentage of aneurysms detected by Viz Aneurysm had not been previously referred for follow-up, highlighting its ability to prevent patients from being lost to care. The platform facilitates communication and can activate referrals to clinics, thereby enhancing adherence to management guidelines.
Viz.ai provides comprehensive training and ongoing support for users of Viz ANEURYSM. This includes access to Viz Academy, which offers clinician-led product training and clinical education content tailored to patient care teams. Additionally, Viz.ai offers 24/7 urgent phone support, dedicated on-call clinical specialists, implementation experts, and a customer success team to assist with any needs.
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| Last Verified: 2026-04-19 | First Added: 2026-04-19
Investors who backed Viz ANEURYSM
Funded through the company that built this tool.
