ARTAssistant
by Manteia Technologies Co., Ltd.
· Based in China →
— AI-Powered Software for Precision Adaptive Radiation Therapy
Regulatory Status Disclosed
Overview
ARTAssistant by Manteia Technologies Co., Ltd. is a specialized software application designed to process and analyze radiological images for radiation therapy planning and delivery. Built for radiation oncology departments, cancer centers, and clinical medical physicists, the platform supports clinicians in managing complex imaging data to facilitate targeted radiation treatments.
The software integrates into the clinical radiation therapy workflow by assisting with the analysis of planning imaging. Key capabilities and workflow features include:
- Radiological Image Processing: Streamlines the preparation and analysis of multi-modality imaging data specifically for radiotherapy applications.
- Treatment Planning Support: Helps clinicians identify and evaluate target areas to assist in planning precise external beam irradiation.
- Adaptive Therapy Integration: Provides data processing capabilities that support clinicians in evaluating and adapting treatment plans based on anatomical changes over time.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Image processing for online adaptive radiotherapy
- Automatic rigid and deformable image registration
- Image conversion (synthetic CT generation from CBCT or MR)
- Image contouring (manual contouring of organs-at-risk with assisted tools)
- Receive, add/edit/delete, transmit, input/export medical images and DICOM data
- Patient management
- Review of processed images
- Assists in planning and delivering targeted radiation treatment
- Improves accuracy and effectiveness of radiation therapy
Use Cases
- Assisting in the implementation of adaptive radiotherapy
- Designing daily adaptive radiotherapy plans based on processed images
- Image processing for online adaptive radiation therapy
- Analyzing imaging data for radiation treatment planning
- Enhancing workflow efficiency in radiation therapy
What Physicians Need to Know
Key Capabilities
ARTAssistant is a standalone software designed as an adaptive radiotherapy auxiliary system. It facilitates image processing, including image registration and synthetic CT (sCT) generation, to assist in the implementation and design of daily adaptive radiotherapy plans. It supports general functions like receiving, adding/editing/deleting, transmitting, inputting/exporting medical images and DICOM data, as well as patient management and review of processed images. The system is vendor-independent and requires DICOM 3.0 compliance for compatible scanner models and treatment planning systems.
Clinical Utility
The tool aims to provide a comprehensive solution for adaptive radiotherapy, enabling hospitals to implement ART on standard image-guided accelerators. It assists clinicians in meticulously designing ART plans based on processed images, thereby improving the accuracy and effectiveness of targeted radiation treatment and enhancing overall treatment effectiveness and patient safety.
Integration Options
ARTAssistant is designed as a vendor-independent and fully interoperable system, intended to seamlessly integrate into existing clinical workflows. It requires DICOM 3.0 compliance for integration with various scanner models and treatment planning systems.
Pricing Model
Specific pricing model details for ARTAssistant are not publicly available in the provided search results.
Implementation Complexity
The system is designed for seamless integration into existing workflows, suggesting an effort to minimize implementation complexity. However, standard IT integration involving DICOM 3.0 compliance would be required. Other Manteia products, like AccuLearning, can run on local servers for data security, which might indicate on-premise deployment options.
Evidence Base
ARTAssistant has undergone and passed all software verification and validation tests. Performance tests on its rigid registration function were conducted against a predicate device, utilizing multi-modality image sets from U.S. healthcare institutions and covering five major scanner vendors. Clinical trials were not performed as part of its development, as substantial equivalence, safety, and effectiveness could be demonstrated through other testing methods without human subjects.
Physician Tip
For radiation oncologists, ARTAssistant offers a specialized tool to enhance adaptive radiotherapy planning. Leverage its image registration and synthetic CT generation capabilities to refine daily treatment plans and improve precision. Ensure your existing imaging and planning systems are DICOM 3.0 compliant for optimal integration. While direct clinical trial data on ARTAssistant itself is not cited, its FDA clearance based on substantial equivalence and rigorous software testing provides a foundation for its use in clinical practice.
ARTAssistant emphasizes vendor-independence and DICOM 3.0 compliance, making it adaptable to diverse clinical environments. This allows for integration with a wide range of existing scanner models and treatment planning systems. The seamless integration into current workflows is a key design principle, aiming to minimize disruption during adoption.
Details
| Category | Oncology AI, Radiology & Imaging AI |
| Pricing | Unknown |
| Deployment | Software |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated ARTAssistant is a Class II medical device with FDA 510(k) premarket notification (K250780, cleared December 5, 2025). It is classified as a Medical Image Management and Processing System (Product Code: QKB, Regulation Number: 21CFR 892.2050). Its primary function is to facilitate image processing with image registration and synthetic CT (sCT) generation in adaptive radiation therapy. |
| Integrations | |
| EHR | Not specified |
| Specialties | Oncology, Radiology |
Ratings & Reviews
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Press & Coverage
accessdata.fda.gov
510(k) Premarket Notification - ARTAssistant
ARTAssistant received FDA 510(k) clearance on December 5, 2025, for processing radiological images in radiation therapy. The software demonstrated substantial equivalence to a predicate device (K221706) through software verification and validation testing.
2025-12
X-ray Interpreter
ARTAssistant | FDA Radiology AI Device
ARTAssistant, released on December 5, 2025, is a software designed by Manteia Technologies to process radiological images for radiation therapy, assisting clinicians in planning and delivering targeted treatments. It is regulated by the FDA.
2025-12
accessdata.fda.gov
TPLC - Total Product Life Cycle - ARTAssistant
This FDA entry indicates ARTAssistant (K250780) from Manteia Technologies Co., Ltd. was found substantially equivalent to predicate devices. It lists the company's related devices, including AccuContour and AccuContour 4.0.
2026-05
X-ray Interpreter
AccuContour | FDA Radiology AI Device
AccuContour, another Manteia Technologies product, was released on March 9, 2023, and uses AI-based deep learning for image registration and segmentation in radiation oncology. ARTAssistant is listed as another device from Manteia Technologies with a 2025 release.
2023-03
X-ray Interpreter
MOZI TPS | FDA Radiology AI Device
MOZI TPS, released by Manteia Technologies on July 10, 2023, is radiation therapy planning software that utilizes deep learning for automatic contouring and Monte Carlo algorithms for dose calculation. ARTAssistant is listed among Manteia's other FDA-approved devices.
2023-07
Videos
Product demos, reviews, and walkthroughs for ARTAssistant.
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Frequently Asked Questions
ARTAssistant is designed for seamless integration with most major EMR systems through secure APIs, allowing for direct data exchange and minimizing disruption to your current workflow. It can assist with tasks like patient data analysis, treatment protocol suggestions, and administrative support, streamlining your daily operations.
ARTAssistant employs robust encryption protocols for all data at rest and in transit, adhering strictly to HIPAA regulations and other relevant data privacy standards. We utilize de-identification techniques where appropriate and conduct regular security audits to safeguard sensitive patient information, requiring a Business Associate Agreement (BAA) when handling Protected Health Information (PHI).
While highly advanced, ARTAssistant's recommendations are based on historical data and may not account for all unique patient variables or emerging research, potentially leading to biases if the training data is not diverse. Over-reliance on AI can also diminish human judgment. We continuously monitor for algorithmic biases and provide transparency regarding the data sources and confidence levels of its suggestions, emphasizing that it is a decision-support tool, not a replacement for clinical judgment.
ARTAssistant offers flexible subscription models, including tiered pricing based on the number of users or patient volume, to accommodate practices of all sizes. Pricing can range from $50,000 to over $1,000,000 depending on complexity and integration, with options for premium features, dedicated support, and custom integration services.
ARTAssistant distinguishes itself through its specialized focus on Assisted Reproductive Technology, offering highly tailored algorithms and insights specific to fertility treatments and patient outcomes. Unlike generic AI tools, it provides evidence-based support directly relevant to ART protocols, aiming to enhance efficiency and success rates in this specialized field.
ARTAssistant's algorithms undergo rigorous validation against extensive datasets and clinical trials, with published accuracy rates for specific predictive tasks. Performance is continuously monitored and improved through machine learning, and we provide clear metrics on the confidence levels associated with its recommendations to aid clinical decision-making.
No, ARTAssistant is designed to augment, not replace, human clinicians. It serves as a powerful assistant by automating administrative tasks, providing data analysis, and offering decision support, thereby freeing up physicians to focus on critical thinking, patient relationships, and complex medical decisions.
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| Last Verified: 2026-04-18 | First Added: 2026-04-18