Regulatory, Quality & Intellectual Property
Regulatory milestones, quality systems and IP portfolio
Verifiable regulatory milestones, quality systems and patent strategy underpinning the credibility of the Liger platform and DeepBT® brain-tumor AI — each item tied to a source and review status.
- Liger TFDA · 008624
- FDA 510(k) K252190
- TFDA · 008460
- ISO 13485 · IEC 62304
Licenses & certifications
TFDA / FDA clearances, ISO 13485 and awards — view the documents
Click any card to enlarge the document; filter by license, certification or award.
Regulatory & quality milestones
Certificate-grade evidence with sources and review status
Liger MedAI Platform · TFDA Class II Clearance
Liger 平台 · TFDA 第二類醫療器材許可
The Liger medical-imaging AI integration platform holds Taiwan TFDA Class II medical device clearance (License No. 008624) — a cleared deployment backbone that can host multiple AI modules and connect to DICOM/PACS workflows.
DeepBT® Detector Plus · TFDA Class II Clearance
DeepBT® Detector Plus · TFDA 第二類醫療器材許可
DeepBT® Detector Plus holds Taiwan TFDA Class II clearance (License No. 008460) as an AI-assisted brain-tumor analysis system; the first-generation DeepBT® Detector is also cleared (No. 007906).
U.S. FDA 510(k) Clearance · K252190
美國 FDA 510(k) · 2026-04-10
DeepBT® Detector Plus received U.S. FDA 510(k) clearance (K252190, decision April 10, 2026, Substantially Equivalent) — the only brain-tumor AI product on the Taiwan market with both TFDA and FDA clearance.
官方來源 · Official sourceISO 13485 Quality Management System
ISO 13485 品質管理系統
ISO 13485 quality-management-system certification (SGS) covering design controls, risk management, verification and validation, post-market surveillance and change management for radiological image-analysis software.
IEC 62304 Medical Software Life Cycle
IEC 62304 醫療軟體生命週期
Product development follows the IEC 62304 medical-device software life-cycle standard, with full software verification and validation (V&V) processes supporting SaMD traceability and safety.
Manufacturing & Distribution Licenses
醫療器材製造業與販賣業許可
Taiwan MOHW medical-device manufacturing (QMS2129) and distribution licenses, supporting full life-cycle management from development and QMS to pre-market preparation and post-market maintenance.
Multicenter validation summary
Standalone performance (multinational, retrospective)
Standalone performance was evaluated on a multinational, multicenter retrospective dataset of 136 clinical cases and 360 tumors from 16 institutions (15 U.S., 1 Taiwan). Ground-truth contours were established by three U.S. board-certified radiologists under strict consensus; training data included over 6,500 MRI studies from two major Taiwanese medical centers.
- 136
- 臨床病例 / Clinical cases
- 360
- 腫瘤 / Tumors
- 16
- 機構 / Institutions
- 6,500+
- 訓練 MRI studies
- 3
- board-certified radiologists
以下性能摘要源自多中心回溯性驗證資料，正式公開前須經法規／臨床／QA 審核確認
病灶層級敏感度
Lesion-wise Sensitivity
待審核病灶層級 Dice 係數
Lesion-wise Dice Coefficient
待審核偽陽性率
False Positive Rate
待審核平衡平均 Hausdorff 距離
Balanced Average Hausdorff Distance
待審核質心距離
Centroid Distance
待審核AI 產生之輪廓僅作為輔助參考，所有結果皆須由合格醫療專業人員審閱、確認或修改後，方可用於後續治療計畫流程。
AI-generated contours are preliminary references only and must be reviewed, confirmed, or modified by qualified medical professionals before clinical use.
Clinical deployment
In use across major medical centers in Taiwan
Taichung Veterans General Hospital
台中榮民總醫院
Shin Kong Wu Ho-Su Memorial Hospital
新光吳火獅紀念醫院
Taipei Veterans General Hospital
台北榮民總醫院
Listed by name (hospital logos pending authorization). Additional medical centers are in trial discussions.
Technology moat & IP portfolio
Not just a model — algorithm, workflow, platform and deployment are all protected
AItewan has established an intellectual property portfolio covering AI-based medical imaging, brain tumor analysis, image processing, clinical workflow integration, and medical software applications.
13
Patents granted
16
Applications pending
3
Trademarks
Filing regions: Taiwan · U.S. · Japan · Europe · China · Malaysia · Vietnam
World-first bi-parametric core
Unlike most brain-imaging AI that relies on a single MRI parameter, DeepBT® analyzes T1W+C and T2W in tandem. This bi-parametric method is core patent-protected across five facets: image acquisition, parameter combination, model-analysis pipeline, lesion-interpretation logic and system architecture.
Algorithm + workflow dual-track protection
Even a competitor that bypasses the algorithm would still infringe if it copies the high-efficiency AI computation-management and platform-integration flow. The entire path — from single-point tool to end-to-end platform — is IP-protected.
Pre-positioned for cloud & cross-system models
The newly granted Medical-Data AI Computation Management Method patent pre-positions IP and regulatory groundwork for a pay-per-use cloud AI service, securing exclusivity as the cloud platform engages hospitals and end users directly.
Multi-country filing strategy
DeepBT® and the Liger platform are filed across Taiwan, the U.S., Japan, Europe, Malaysia and Vietnam. U.S./EU filings target high-end imaging and AI-medical commercialization; Southeast-Asia filings secure early entry into fast-growing smart-healthcare markets.
AI-Based Brain Tumor Image Analysis
AI 腦部腫瘤影像分析
Deep-learning methods for brain MRI analysis, tumor region detection, contour generation and image-feature extraction.
Automatic Tumor Contouring & Segmentation
自動腫瘤圈註與分割
Automated and semi-automated contouring techniques for brain metastases, meningiomas and acoustic neuromas.
Multimodal MRI Processing
多模態 MRI 處理
Integration of T1W+C, T2W and other MRI sequences for boundary analysis, registration, feature fusion and AI inference.
DICOM-Based Workflow Integration
DICOM 臨床流程整合
Conversion of AI results into standardized DICOM objects (PR, RTSS, SEG, SR) and integration with PACS, TPS and clinical imaging workflows.
Radiotherapy Planning Support
放射治療計畫支援
Application of AI-generated contours to radiotherapy planning preparation, physician review and clinical data exchange.
Medical AI Platform & SaMD Architecture
醫療 AI 平台與 SaMD 架構
Medical-AI platform, model management, background inference, workflow automation and medical-software system architecture.
Representative patent certificates
| Patent Title | Patent No. | Region | Status | Related Product |
|---|---|---|---|---|
| Medical image processing method and system | I901468 | Taiwan | Granted | Liger platform |
| Medical-data AI computation management method | 114124520 | Taiwan | Notice of allowance | Liger platform |
| Method and apparatus for performing restoration | I873807 | Taiwan | Granted | Liger platform |
| Brain medical-image processing method and system | 113147090 | Taiwan | Notice of allowance | Liger platform |
| Brain tumor types distinguish system | I830161 | Taiwan | Granted | DeepBT® |
| Brain Tumor Types Distinguish System | US 12,499,543 B2 | U.S. | Granted | DeepBT® |
| Benign tumor development trend assessment system | I743693 | Taiwan | Granted | DeepBT® |
| Benign Tumor Development Trend Assessment System | US 11,475,563 B2 | U.S. | Granted | DeepBT® |
| Method for Enhancing Assessment Accuracy | US 12,381,014 B2 | U.S. | Granted | DeepBT® |
| Benign tumor development trend assessment system | P7198300 | Japan | Granted | DeepBT® |
| Benign tumor development trend assessment system | 202110199633.X | China | Granted | DeepBT® |
| Brain Tumor Types Distinguish System | EP22199621.8 | Europe | Allowance notice | DeepBT® |
Granted and notice-of-allowance patents are shown with their certificate-confirmed numbers; applications still under examination are described as patent-filed / pending, without disclosing unpublished technical detail.
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