AiORTA – Plan
Contact for pricing
Regulatory Status Disclosed
Overview
AiORTA – Plan by ViTAA Medical Solutions is a US FDA 510(k) cleared, fully automated, hyper-precise aortic surgery planning solution. It is designed to automate key preoperative measurements and streamline aortic case preparation, generating a complete aortic plan in minutes through a zero-footprint, web-based system. The tool performs automated aneurysm segmentation, centerline extraction, precise diameter and angulation measurements, and instant volumetric modeling, providing highly accurate and reproducible results. AiORTA – Plan is the initial component of ViTAA’s broader AiORTA platform, which also includes AiORTA Maps (for patient-specific vessel strength analysis) and AiORTA Watch (for longitudinal monitoring), both currently in multicenter clinical studies.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Automated aneurysm segmentation
- Centerline extraction
- Precise diameter and angulation measurements
- Instant volumetric modeling/analysis
- Web-based, zero-footprint system
- Streamlines aortic case preparation
- Reduces manual planning work
- Improves planning consistency and reproducibility
- Provides adjunct information for healthcare practitioners
- Supports pre-operative evaluation and sizing
Use Cases
- Pre-operative planning for complex aortic procedures
- Assessment of aortic aneurysms
- Sizing for cardiovascular intervention and surgery
- Post-operative evaluation in patients 22 years and older
- Streamlining aortic case preparation workflows
- Identifying vulnerable areas of the aorta
What Physicians Need to Know
DICOM Support & Standards
AiORTA - Plan's analysis pipeline processes input from DICOM images for volumetric assessment of cardiovascular CTA scans.
PACS Integration Method
The tool is a cloud-based, zero-footprint, web-based system designed to integrate seamlessly into existing clinical workflows.
Reading Room Workflow Impact
AiORTA - Plan automates key preoperative measurements, including aneurysm segmentation, centerline generation, and volumetric analysis, to streamline aortic case preparation. It aims to improve precision and reproducibility while reducing manual planning work, generating a complete aortic plan in minutes.
AI Model Architecture (deep learning approach)
It is an AI-based tool that automates complex image analysis tasks such as aneurysm segmentation, centerline extraction, and volumetric modeling, likely leveraging deep learning techniques for 3D reconstruction and measurement from CT scan data.
Processing Speed (per study)
The system is capable of generating a complete aortic plan in minutes.
FDA Clearance Pathway (510k/De Novo)
AiORTA - Plan received FDA 510(k) clearance (K250337) as a Class II medical device.
Supported Modalities (CT/MRI/X-ray/US)
The software uses cardiovascular CTA scans (CT scans) as input for its analysis.
Sensitivity & Specificity Data
Specific sensitivity and specificity data for AiORTA - Plan are not explicitly detailed in the provided information. The FDA clearance document mentions acceptance criteria for landmark distance and segmentation accuracy.
RSNA/ACR Validation
Direct validation by RSNA or ACR for AiORTA - Plan is not mentioned in the available information.
Physician Tip
AiORTA - Plan serves as an adjunctive tool to assist physicians in preoperative evaluation, planning, and sizing for cardiovascular interventions and surgery, particularly for aortic aneurysms. It can significantly reduce manual planning time and improve consistency in measurements. Physicians should integrate its rapid, automated volumetric analysis and 3D reconstructions into their existing workflow to enhance decision-making, but always in conjunction with clinical data and other diagnostic inputs, as it is not intended for stand-alone diagnosis.
As a cloud-based, web-accessible system, AiORTA - Plan is designed for seamless integration into existing clinical workflows. Its reliance on DICOM images as input means it can interface with standard imaging archives. For optimal utility, ensure robust network connectivity and consider how its web-based output will be accessed and incorporated into PACS and EHR systems to maintain a cohesive patient record and reporting process.
Details
| Category | Radiology & Imaging AI, Surgical AI |
| Pricing | Contact for pricing |
| Deployment | Cloud-based |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated AiORTA - Plan received US FDA 510(k) clearance (K250337) on October 30, 2025. It is classified as an Automated Radiological Image Processing Software (Class II - Special Controls, product code QIH). |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiothoracic Surgery, Radiology, Vascular Surgery |
Ratings & Reviews
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Press & Coverage
Vascular News
ViTAA Medical announces US FDA 510(k) clearance for aortic planning platform
ViTAA Medical received FDA 510(k) clearance for AiORTA Plan, a fully automated, hyper-precise aortic surgery planning solution, marking a significant milestone for the company's broader AiORTA platform. The tool aims to streamline preoperative measurements and generate complete aortic plans in minutes through a web-based system.
2025-11
IGMPI
ViTAA's AiORTA Plan Receives FDA Clearance - IGMPI
ViTAA Medical secured FDA clearance for AiORTA Plan, an AI-powered tool that automates key preoperative tasks for complex aortic surgeries, including aneurysm segmentation and volumetric analysis. This is the first component of their full-suite aortic care platform, which will also include AiORTA Maps and AiORTA Watch.
2025-11
Pharma Technology Focus
FDA clears ViTAA Medical's AI aortic surgery planning tool
ViTAA Medical's AiORTA Plan, an AI-based tool for aortic surgery planning, has gained FDA clearance, representing the first step in the company's goal to bring a comprehensive aortic care platform to market. The tool assists physicians in preparing for complex aortic procedures by automating key measurements.
2025-11
Financial Post
ViTAA Medical Secures FDA 510(k) Clearance for AiORTAu2122 Plan -- Marking the First Step in Its Hyper-Precise Aortic Care Platform | Financial Post
ViTAA Medical Solutions Inc. announced FDA 510(k) clearance for AiORTAu2122 Plan, its automated aortic surgery planning solution, a foundational milestone for its broader AiORTAu2122 platform. The platform aims to provide end-to-end, patient-specific vascular care, with AiORTAu2122 Maps and AiORTAu2122 Watch currently in clinical studies.
2025-11
FDA.gov
Artificial Intelligence-Enabled Medical Devices - FDA
The FDA lists AiORTA - Plan v2.0 by ViTAA Medical Solutions, Inc. as an authorized AI-enabled medical device for radiology, specifically for volumetric assessment, image analysis, geometric analysis, and pre-operative sizing and planning. This resource provides transparency for healthcare providers and patients regarding AI technologies in medical devices.
2026-03
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances - Innolitics
AiORTA - Plan from ViTAA Medical Solutions Inc. is listed among the cardiology AI/ML SaMD 510(k) clearances in 2025, with its clearance date in October 2025. This article provides an overview of AI-enabled medical device clearances in cardiology.
2026-01
AiORTA.com
ViTAA Medical Solutions - Physician Ai Tools
ViTAA Medical Solutions highlights AiORTA Plan as an AI-based tool for physicians, with its FDA clearance. The company's AiORTA suite also includes AiORTA Watch and AiORTA Maps, which are currently in clinical studies to provide deeper insights into vascular biomechanics.
2026-04
Vascular News
AAA Archives - Vascular News
Vascular News frequently covers updates related to abdominal aortic aneurysms (AAA), including the FDA 510(k) clearance for ViTAA Medical's AiORTA Plan. The platform is described as a fully automated, hyper-precise aortic planning solution.
2026-06
Videos
Product demos, reviews, and walkthroughs for AiORTA – Plan.
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Frequently Asked Questions
AiORTA - Plan is designed to seamlessly integrate with common EHR systems, providing AI-driven insights directly within your existing patient records. It primarily assists with treatment planning, risk assessment, and personalized patient pathway recommendations, aiming to streamline decision-making and enhance efficiency.
AiORTA - Plan employs robust encryption protocols for data at rest and in transit, adheres to strict access controls, and undergoes regular security audits to ensure HIPAA compliance. All patient data is de-identified or anonymized where appropriate to protect privacy, and Business Associate Agreements (BAAs) are in place with all vendors handling Protected Health Information (PHI).
Yes, AiORTA - Plan has obtained regulatory clearance as a medical device for its intended clinical applications, such as FDA clearance as a Class II medical device or CE Mark certification. This ensures it meets stringent safety and efficacy standards for healthcare use, following frameworks like the FDA's AI/ML-Based Software as a Medical Device (SaMD) Action Plan.
AiORTA - Plan distinguishes itself through its proprietary algorithms, which offer superior predictive accuracy and highly customizable planning modules for specific conditions like complex aortic diseases. While traditional methods rely on manual data analysis, AiORTA - Plan provides real-time, data-driven insights for more efficient and personalized care, often integrating multimodal data like genetics and imaging.
AiORTA - Plan typically operates on a tiered subscription model, with pricing based on factors like user count, feature access, and data volume. Flexible plans are designed to accommodate solo practices, small clinics, and larger hospital systems, often incorporating hybrid models with a base fee and variable components.
While powerful, AiORTA - Plan's recommendations are based on available training data and may not account for all unique patient circumstances or rare conditions, potentially perpetuating biases present in the data. It is intended as a decision-support tool, and physician oversight remains crucial for final clinical decisions, ethical considerations, and empathetic patient communication, as AI cannot fully replicate human judgment or empathy.
Comprehensive training programs and ongoing support are provided to ensure physicians can effectively integrate AiORTA - Plan into their practice. This includes onboarding, user guides, and access to support specialists, aiming to address concerns about adequate training for AI technologies in healthcare.
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| Last Verified: 2026-04-21 | First Added: 2026-04-21