Certification Timeline

Taiwan

2022: Osteoporosis Imaging Analysis Software and Cell Imaging Analysis Software certified as TFDA Class II medical devices

Vietnam

2023: X1 Bone Densitometer Solution certified as MOH Class A and Class B medical devices

Singapore

2021: X1 AI Pathology Solution certified as HSA Class A medical device
2022: X1 Bone Densitometer Solution certified as HSA Class B medical device

Indonesia

2024: X1 Bone Densitometer Solution certified as a medical device

Thailand

2024: X1 Bone Densitometer Solution certified as a medical device

United States

2020: X1 AI Medical Imaging Diagnostic Pro certified as FDA Class II medical device

Company Awards Timeline

 

2025

  • Winner of the 22nd National Innovation Award Category: International Innovation & Outstanding Technology in Innovative Medical Devices and Diagnostics
    • Biomdcare’s proprietary AIXA system has distinguished itself in the "Innovative Medical Devices and Diagnostics" category through its exceptional technological innovation. Designed specifically for adults, AIXA provides highly efficient and precise rapid assessments for osteoporosis, sarcopenia, and fracture risks, demonstrating our leadership in the field of precision medicine.
  • Official Certification: Registered AI Technical Service Organization
    • Biomdcare has officially received the "AI Technical Service Organization" registration certificate from the Administration for Digital Industries (ADI), Ministry of Digital Affairs. This certification serves as official recognition of our technical maturity and industry-leading capabilities in applying AI to the healthcare sector.
  • Global Connectivity: Certified in IHE Dual-Test Integration
    • Biomdcare successfully passed the international IHE (Integrating the Healthcare Enterprise) dual-test certification. This milestone signifies that our AI medical data exchange capabilities align with top-tier global standards. We have successfully implemented cross-border medical data exchange between Taiwan, Japan, and South Korea (supporting FHIR/IPS formats), laying a solid foundation for our global smart healthcare expansion.
  • ISO 13485: Medical Devices — Quality Management System
    • We strictly adhere to ISO 13485 standards, ensuring that every stage of our research, development, and service meets the highest international quality and safety requirements for medical devices.

2024

  • Winner of the TITA 20th Taiwan Golden Root Award
  • Recipient of the SME Innovation Research Award

2023

  • Certified by the Digital Industry Agency of the Ministry of Digital Affairs as an AI Technology Service Provider
  • Selected as a promising startup team in the AAMA AIoT Co-Creation Program, collaborating with Advantech, Chunghwa Telecom, and Syscom Group

2022

  • Champion of the Intel AI Dev CUP x OpenVINO Toolkit Competition – Implementation Category

2021

  • Bronze Award in the X-PITCH Extreme Pitch International Competition

2020

  • Recipient of the Corporate Social Responsibility (CSR) Award
  • The only approved AI Technology Service Provider (Precision Medicine) by the Industrial Development Bureau, Ministry of Economic Affairs
  • First Place in the Southern Taiwan Science Park Biomedical Cluster International Advancement Program (Smart Healthcare)
  • Winner of the SCSE AI50 Campaign

2019

  • Honored with the Chinese Trustworthy Brand Gold Award

2018

  • Recipient of the 25th National Innovation Research Award by the Ministry of Economic Affairs

2016

  • Founding of Biomedica
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