TaiHao Medical

Taipei, Taiwan  All Taiwan companies → Founded 2013
Imaging AI Specialist
General Surgery Oncology Radiology
Oncology AI Radiology & Imaging AI
Private (with strategic investors); Unfunded (no formal rounds reported)

Products

BU-CAD
TaiHao Medical
Oncology AI
First USFDA approved (K210670) computer-aided diagnostic software for detecting potential cancer lesions in ultrasound images.

See all 1 product →

About TaiHao Medical

TaiHao Medical is an artificial intelligence (AI) company specializing in advanced medical imaging software designed to enhance diagnostic accuracy and efficiency for healthcare professionals. Since its establishment in 2013, the company has focused on developing AI-powered solutions that assist physicians and radiologists in interpreting medical images, particularly from ultrasound and low-dose CT (LDCT) scans. Their core offerings, such as the BR-ABVS Viewer, BR-USCAD, and BR-FHUS Smart System, are primarily geared towards breast cancer screening and diagnosis, addressing the increasing workload and the need for standardized, high-quality image interpretation.

TaiHao Medical’s technology integrates image analysis, automatic detection, and auxiliary diagnosis functionalities, aiming to reduce diagnostic time and improve diagnostic accuracy. Their products have received significant regulatory clearances, including 510(k) FDA clearance in the US, Japan’s first medical material license for breast ultrasound AI-assisted screening in 2020, and subsequent US FDA AI license for breast ultrasound lesion detection and diagnosis in 2021. The company also holds medical product licenses in Taiwan, the European Union (CE), South Korea, Thailand, Malaysia, and Vietnam, demonstrating a strong global presence and commitment to rigorous quality standards, as evidenced by their ISO 13485 certification.

Beyond breast imaging, TaiHao Medical is expanding its focus to include AI solutions for lung nodule detection and diagnosis with products like Ti-LUNG™ Decision Support, further broadening its impact on early cancer detection. The company collaborates with major medical centers and academic research institutions to continuously refine its AI technology, aiming to provide comprehensive medical information platforms that streamline workflows, reduce the burden on medical personnel, and ultimately improve patient care and outcomes.

Focus Areas

AI medical imaging software breast ultrasound screening breast cancer diagnosis lung nodule detection computer-aided detection computer-aided diagnosis image analysis reporting systems

Business Intelligence

Key InvestorsCDIB Capital Group, CDIB Capital Healthcare Ventures Limited, Japan CESデカルト, Top Taiwan Venture Capital Co., Ltd., CTBC Securities Venture Capital Co., Ltd.
PartnershipsFerrum Health, GE HealthCare, FujiFilm Healthcare, major medical centers, academic research institutions
TechnologyAI medical imaging software, real-time AI detection, image analysis, automatic detection, auxiliary diagnosis, reporting system, system integration
FDA Clearances4 cleared products (estimated)

What Physicians Need to Know

Specialized AI Medical Imaging
TaiHao Medical specializes in AI-powered software for medical imaging, primarily focusing on breast ultrasound screening and diagnosis, as well as lung nodule detection and diagnosis.
Breast Cancer Screening & Diagnosis
Their products, including BR-Viewer, BR-FHUS Smart System (Navigation and Viewer), and BU-CAD, offer solutions for both handheld and automated breast ultrasounds. These systems assist in detecting breast lesions, providing BI-RADS classification, and generating structured reports.
Lung Nodule Detection & Diagnosis
The Ti-LUNG Decision Support system analyzes low-dose CT (LDCT) images to identify suspected lung nodule areas, evaluate their benign or malignant levels, and provide Lung-RADS classification. It also includes an optional Coronary Artery Calcification (CAC) analysis module.
Computer-Aided Detection & Diagnosis (CAD/CADx)
A core component across their offerings, TaiHao Medical's software utilizes computer-aided detection and diagnosis to enhance the efficiency and accuracy of image interpretation for both breast and lung conditions.
Image Analysis & Reporting Systems
Their platforms integrate advanced image analysis capabilities with automated reporting systems, facilitating the generation of comprehensive and structured diagnostic reports.
Physician Tip

TaiHao Medical's solutions are designed to significantly reduce physician workload and combat burnout by automating detection and report generation, allowing more focus on patient care. Physicians can expect improved diagnostic confidence and reduced missed detection rates, as the AI acts as an 'extra specialist' providing real-time alerts and assistance, particularly beneficial for less experienced radiologists. The standardization of handheld ultrasound scanning processes helps ensure consistent image quality and increases scanning capacity, lessening the reliance on extensive individual experience. Furthermore, the rapid generation of structured reports, including BI-RADS and Lung-RADS classifications, streamlines the reporting workflow. For lung screenings, the integrated CAC module offers early cardiovascular risk assessment from a single CT scan, maximizing diagnostic value without additional radiation. TaiHao's AI models are built on pathological cases and clinical tests, ensuring high accuracy, sensitivity, and specificity, backed by clinical trials in the US, Japan, and Taiwan.

TaiHao Medical's software is designed for compatibility with existing medical imaging infrastructure. Their products receive images in DICOM format from Picture Archiving and Communication Systems (PACS), radiology information systems, or directly from CT scanners. The BR-FHUS Navigation and Viewer are standalone software devices installed on Windows-based computers. BU-CAD can also function as an image viewer for multi-modality digital images, including ultrasound and mammography. TaiHao also offers professional system integration services to upgrade existing systems and platforms with their AI technology.

Products by TaiHao Medical

1 product in the directory

BU-CAD
TaiHao Medical
Oncology AI
First USFDA approved (K210670) computer-aided diagnostic software for detecting potential cancer lesions in ultrasound images.

Reviews & Opinions

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Press & Coverage

TaiHao Medical Inc.
TaiHao Takes Southeast Asia by Storm: Expanding into Malaysia and Vietnam!
TaiHao Medical announced its expansion into Southeast Asia, deploying AI-assisted diagnostic systems in the Philippines, Malaysia, and Vietnam. This marks a new chapter in their global journey, showcasing Taiwan's medical technology.
2024-08
TaiHao Medical Inc.
TaiHao Medical Exhibited at 2023 RSNA
TaiHao Medical participated in the 2023 RSNA conference, an event where they likely showcased their advanced AI medical imaging solutions.
2024-05
Institute for Biotechnology and Medicine Industry (IBMI)
TaiHao Medical Inc. Launches AI Medical Devices in Southeast Asia
TaiHao Medical Inc., a Taiwanese AI medical imaging leader, announced significant international developments, including the launch of its AI medical devices in Southeast Asia. This demonstrates their technological strength and commercial progress in the global healthcare market.
2025-08
TaiHao Medical Inc.
BR-FHUS Smart System Approved by Malaysia Medical Device Authority (MDA)
TaiHao Medical's BR-FHUS Smart System received approval from the Malaysia Medical Device Authority (MDA), indicating regulatory clearance for market entry in Malaysia.
2024-06
TaiHao Medical Inc.
BU-CAD Approved by TFDA for Expanded Specifications, Applicable to ABUS Imaging
TaiHao Medical's BU-CAD received approval from the Taiwan Food and Drug Administration (TFDA) for expanded specifications, making it applicable to Automated Breast Ultrasound System (ABUS) imaging.
2023-12
ClinicalTrials.gov
Evaluation of TaiHao Breast Ultrasound Diagnosis Software
This retrospective study evaluated the performance of physicians with and without the aid of TaiHao Medical's BU-CAD decision support in interpreting breast ultrasound images. The study found that BU-CAD significantly decreased interpretation times by approximately 40% and improved diagnostic accuracy.
2022-11
TaiHao Medical Inc.
BU-CAD Cleared by U.S. FDA (510(k))
TaiHao Medical's BU-CAD (Breast Ultrasound Lesion Computer-aided Diagnosis Decision Support System) received 510(k) clearance from the U.S. FDA.
2021-12
TaiHao Medical Inc.
BR-FHUS Smart System Approved by Japan PMDA
TaiHao Medical's BR-FHUS Smart System received approval from the Japan Pharmaceuticals and Medical Devices Agency (PMDA).
2020-12

Frequently Asked Questions

TaiHao Medical provides several AI-powered solutions for breast cancer, including the BR-FHUS Smart System for both handheld and automated breast ultrasound screening, and BU-CADu2122 for diagnostic assistance in breast cancer detection. These products offer features like real-time suspicious finding alerts, scanning quality assurance, and diagnostic support to enhance efficiency and accuracy.
TaiHao Medical offers Ti-LUNGu2122 Decision Support, an AI software designed for lung nodule detection and diagnosis using low-dose CT (LDCT) images. This system assists physicians by identifying suspected nodule areas, evaluating their benign or malignant levels, and providing Lung-RADS classification. It also includes an optional Coronary Artery Calcification (CAC) analysis module for comprehensive cardiovascular risk assessment.
TaiHao Medical has secured significant regulatory approvals for its AI medical imaging software, including the US FDA's AI license for breast ultrasound lesion detection and diagnosis in 2021, and Japan's first medical material license for breast ultrasound AI-assisted screening in 2020. The company also holds medical product licenses from Taiwan, the European Union (CE), South Korea, Thailand, Malaysia, and Vietnam, alongside ISO13485 medical equipment quality management system certification.
TaiHao Medical's AI solutions are reported to significantly improve clinical efficiency and diagnostic accuracy. Studies indicate that their breast ultrasound AI products can reduce diagnosis time by approximately 40% and improve diagnostic accuracy by 9.4%. The AI software also aims to reduce the workload on medical staff and enhance detection rates by providing real-time assistance and automated analysis.
TaiHao Medical's AI software is designed to integrate with existing medical imaging infrastructure, such as PACS and radiology information systems. The systems provide image analysis, automatic detection, and auxiliary diagnosis, and can automatically generate structured reports after image review, streamlining the reporting process. They also offer system integration services to ensure compatibility with various medical institutions' platforms.
TaiHao Medical offers customized AI billing programs tailored to the needs of medical institutions, though specific pricing models are not publicly detailed and require direct inquiry. For ongoing support, the company provides dedicated sales, product, and technical support teams accessible via email and phone.
Founded in 2013 in Taipei, Taiwan, TaiHao Medical specializes in AI medical imaging software and has established collaborations with major medical centers and academic research institutions. While the company has not publicly reported raising funding rounds as of March 2026, it is supported by shareholders including CDIB Capital Healthcare Ventures Limited and CTBC Securities Venture Capital Co., Ltd.

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