AItewan BioMedical Technology
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Brain Tumor Imaging AI · SaMD

Brain tumor AI contouring, integrated into radiotherapy workflows

DeepBT Detector-Plus generates preliminary tumor contours and returns them as standardized DICOM to PACS / TPS, where physicians review, confirm or modify the results to support radiotherapy planning.

  • FDA 510(k) · K252190
  • TFDA Class II device
  • DICOM PR / RTSS
U.S. FDA 510(k) K252190Liger Platform TFDA · 008624DeepBT® TFDA Class II · 008460DICOM PR / RTSS integrationDeployed in Taiwanese medical centersNational Innovation & Smart Innovation Awards
Platform + Flagship

One platform, one flagship application

Liger MedAI Platform × DeepBT® Brain Tumor AI

AItewan is building a regulated medical-imaging AI infrastructure that bridges AI research, clinical workflow and hospital-scale deployment — with the Liger MedAI Platform as the integration backbone and DeepBT® as the flagship brain-tumor AI application, moving imaging AI beyond standalone algorithms into real clinical operation.

Clinical Problem

Three bottlenecks in brain tumor radiotherapy workflows

Why contouring and workflow integration matter

Manual contouring is a heavy workload

Brain-tumor contours are still largely drawn slice by slice — repetitive, time-consuming, and especially demanding in multi-lesion cases.

Cross-system exchange is complex

Images, structures and plans live across PACS, viewers and TPS; without standardized exchange, workflow burden grows.

AI must fit the existing review flow

If AI results cannot return to the familiar TPS review environment as standard DICOM objects, their value is greatly diminished.

The Solution

An AI-assisted contouring system built for clinical use

DeepBT Detector-Plus · key capabilities

AI-Assisted Tumor Contouring

Generates preliminary contours for diagnosed adult brain tumors as a starting point for physician review.

Explore DeepBT Detector-Plus

Three Cleared Tumor Types

Brain metastases, meningiomas and acoustic neuromas.

Bi-parametric MRI

Supports T1W+C and T2W inputs.

Standardized DICOM Output

DICOM PR / RTSS connects to PACS and TPS.

Physician-Led Review

Every result is confirmed or modified by qualified medical professionals.

Longitudinal Quantification

Provides objective quantitative references for tumor-volume changes.

How It Works

A six-step workflow from MRI to treatment planning

From MRI to treatment-planning support

Clinical scenario showing a physician reviewing AI-assisted brain MRI contours, segmentation masks and report drafts at a workstation
AI-assisted · Physician-led review
  1. 01

    MRI Study

    Eligible brain MRI

    Eligible T1W+C / T2W MRI of diagnosed adult brain tumors.

  2. 02

    PACS / TPS

    Existing systems

    Image data are retrieved from existing PACS or treatment planning systems.

  3. 03

    DeepBT AI Inference

    AI-assisted analysis

    AI inference generates preliminary contours for the cleared brain tumor categories.

  4. 04

    DICOM PR / RTSS Output

    Standardized DICOM

    Standardized DICOM Presentation State and RT Structure Set objects are exported.

  5. 05

    Physician Review

    Review · Confirm · Modify

    Physicians review, confirm or modify AI results in the viewer or TPS.

  6. 06

    Treatment Planning Support

    RT planning preparation

    Confirmed contours serve as a reference for radiotherapy planning preparation.

Core Technology

Core technology from image analysis to clinical integration

AI segmentation · Lesion detection · Workflow integration · Structured reporting

DeepBT integrates deep-learning brain tumor image analysis into clinical workflows, helping teams produce preliminary contours and quantitative references. All AI results are preliminary references and must be reviewed, confirmed or modified by qualified medical professionals.

  • Deep-learning brain tumor segmentation

    Deep learning performs tumor detection and preliminary segmentation on T1W+C and T2W MRI.

  • Multicenter retrospective validation

    Standalone performance was evaluated on multinational, multicenter retrospective data, with ground truth established by board-certified radiologists.

  • DICOM-native clinical integration

    Standard DICOM PR / RTSS flows into existing PACS / TPS without changing the physician's working environment.

  • SaMD system architecture

    Model management, background inference and result return are designed to medical-device software standards.

FastObjectiveQuantitativeAccurateSmooth
DeepBT AI brain tumor analysis dashboard showing axial MRI contours and tumor-volume trend over timeAI Analysis · For Review
Trust & Evidence

Why hospitals and partners trust DeepBT

Cleared, validated, built on real clinical experience

Regulatory & Recognition

A brain tumor AI medical device cleared by the FDA and TFDA

  • U.S. FDA 510(k) Clearance

    U.S. FDA · K252190 · 2026-04-10

  • TFDA Class II Registration (Analysis System)

    Taiwan FDA, MOHW

  • TFDA Class II Registration (Detection System)

    Taiwan FDA, MOHW

  • Future Tech Award

    National Science & Technology Council

Multicenter Validation

Scale of the multinational, multicenter retrospective validation dataset

136

Clinical cases

360

Tumors

16

Institutions

6,500+

Training MRI studies

3

Board-certified radiologists

Standalone performance figures such as sensitivity and Dice are presented on the full clinical-validation page and require regulatory, clinical and QA review before formal publication.

Full regulatory milestones, clinical validation, hospital deployment and patent portfolio

SaMD Consulting

Regulatory expertise backed by real AI SaMD clearance experience

From product development to regulatory clearance

We bring hands-on experience taking our own AI SaMD products from development and hospital deployment through clinical validation to TFDA and U.S. FDA 510(k) clearance, helping medical-AI teams reach clinical deployment.

  • We do not just know the regulations — we have cleared an AI SaMD ourselves
  • We do not just write documents — we understand clinical workflows and DICOM integration
  • We do not just consult — we help build product strategies that actually ship
  • Hands-on TFDA, FDA, ISO 13485, cybersecurity, IP and market-access experience
Contact AItewan

Bring brain tumor AI into clinical workflows with AItewan

Whether you are a healthcare institution adopting AI-assisted contouring or a medical-AI team seeking SaMD regulatory support, we can help from product planning and clinical workflow integration through regulatory clearance.