SGSC Secures Taiwan Medical Device Licence for RadiSen AXIR-CX to Advance AI-Assisted Chest X-ray Imaging
Smart Group Solutions Corp. (SGSC), the Taiwan distributor of RadiSen, has secured a medical device licence issued by Taiwan’s Ministry of Health and Welfare for AXIR-CX, the AI software that powers SGSC’s Chest X-ray AI Screening Solution. Classified as Software as a Medical Device (SaMD), AXIR-CX represents an important milestone in SGSC’s expansion of its medical imaging AI portfolio. SGSC will combine product distribution with local system integration and technical support to help healthcare providers in Taiwan adopt medical imaging AI and advance its use in clinical practice.
SGSC Secures Taiwan TFDA License for AI-Assisted Chest X-ray Solution.
AI-Assisted Chest X-ray Analysis to Support Timely Clinical Interpretation
Chest X-ray is widely used in outpatient clinics, inpatient wards, emergency departments and health screening programmes. As medical imaging volumes continue to grow, healthcare providers are evaluating not only the functionality and performance of AI algorithms, but also whether these solutions can connect reliably with existing imaging equipment and Picture Archiving and Communication Systems (PACS) and fit within established image interpretation workflows. Coordinated planning across product capabilities, IT architecture and clinical operations is therefore essential to the successful deployment and sustained use of medical AI.
AXIR-CX is AI-assisted screening software designed for chest X-ray images. It processes standard Digital Imaging and Communications in Medicine (DICOM) images and provides abnormality analysis with visual annotations to support physician interpretation. The software can assist in identifying findings including atelectasis, pulmonary fibrosis, masses or nodules, pleural effusion, pneumothorax, hilar abnormalities and lung opacities. It also provides image analysis related to pneumonia and tuberculosis (TB), giving physicians timely and clinically relevant information to support image interpretation.
Beyond Taiwan, AXIR-CX has been deployed in Southeast Asian markets including the Philippines, Thailand, Vietnam and Indonesia. These deployments have built practical experience across diverse healthcare settings and generated positive feedback from local users and partners, demonstrating the solution’s potential for use in different clinical environments.
In high-volume screening settings, AXIR-CX results can also serve as an additional reference for risk stratification and worklist prioritisation. This can help medical teams identify images with suspected abnormalities or higher-risk findings earlier, streamline interpretation workflows and allocate clinical resources more effectively, enabling cases that require further assessment to receive timely attention.
From Product Distribution to Local Deployment and System Integration
For healthcare providers, implementing medical imaging AI involves more than installing software. DICOM images must be securely routed to the AI system, analysis results must be returned and displayed appropriately, and the solution must connect with existing PACS, imaging equipment and physician workflows. Because equipment brands, IT architectures, cybersecurity requirements and clinical processes vary by institution, each deployment must be planned around the hospital’s specific operating environment.
In addition to distributing and promoting AXIR-CX in Taiwan, SGSC applies its healthcare IT integration experience to address PACS connectivity and radiology workflow integration. From requirements assessment and deployment-environment evaluation to system planning, implementation, user training and ongoing technical support, SGSC connects RadiSen’s technology with local implementation resources. This helps healthcare providers reduce the complexity of system deployment and cross-platform integration while embedding AI-assisted analysis more seamlessly into existing imaging workflows.
Strengthening SGSC’s Medical AI and Digital Radiography Portfolio
The Taiwan medical device licence marks AXIR-CX’s formal entry into the Taiwan market and further strengthens SGSC’s solutions portfolio in medical imaging AI and digital radiography. By introducing international medical technologies and combining them with local project delivery and system integration expertise, SGSC helps healthcare providers translate innovation into practical applications that align with clinical requirements and support reliable day-to-day operations.
In addition to AXIR-CX, SGSC offers a Portable Digital X-ray System integrating a mobile X-ray unit, a flat panel detector (FPD) and imaging workstation software. Its high mobility supports imaging needs in inpatient wards and emergency departments, as well as in remote or medically underserved areas, helping improve access to diagnostic imaging and interpretation resources for primary-care and rural communities. The system can also be paired with AXIR-CX to connect image acquisition, image transmission and AI-assisted analysis in a unified workflow. This creates an integrated solution spanning mobile imaging and AI-assisted interpretation while further strengthening SGSC’s digital radiography portfolio.
Looking ahead, SGSC will continue to deepen its capabilities across smart hospital implementation, medical data integration and interoperability, clinical AI applications, digital radiology and specialised medical equipment. From strategic planning and system deployment to ongoing operations and maintenance, SGSC provides end-to-end, practical and scalable smart healthcare solutions that support long-term use and accelerate healthcare digital transformation.
| Product Name | “Radisen” Automatic X-Ray Image Reader for Chest |
| Model | AXIR-CX |
| Taiwan Distributor | Smart Group Solutions Corp. (SGSC) |
| Medical Device Licence No. | TFDA Medical Device Registration No. 039100 |
