Certification Timeline

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

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

2021: X1 AI Pathology Solution certified as HSA Class A medical device

2022: X1 Bone Densitometer Solution certified as HSA Class B medical device

2024: X1 Bone Densitometer Solution certified as a medical device

2024: X1 Bone Densitometer Solution certified as a medical device

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

Company Awards Timeline

Completed external clinical validation of AIXA® Osteo in Japan's clinical environment in partnership with Dokkyo Medical University Saitama Medical Center, with results published in the European Journal of Radiology.
Biomedica X1 Osteoporosis officially obtained regulatory registration approval in the Philippines.
 Launched an academic collaboration with Chiang Mai University Hospital in Thailand to conduct clinical validation of AIXA Osteoporosis.

Received the National Innovation Award — International Innovation Award.
Awarded the "Digital Service Organization Capability Registration Certificate" by the Administration for Digital Industries, Ministry of Digital Affairs.
Obtained the IHE Japan interoperability connectathon certification.
Achieved ISO 27001 certification.
Flagship AI product AIXA® Osteo secured Marubeni Corporation (Japan) as its general distributor.

Winner of the TITA 20th Taiwan Golden Root Award
Recipient of the SME Innovation Research Award
Selected as a finalist in the "Top 100 Startups" competition (Biotechnology, Pharmaceuticals, and Medical Devices category).
Certified in the Medical Imaging and Pathology track by the Taiwan Medical Informatics Joint Testing.
Obtained Thailand medical device approval and entered the local market
Obtained Indonesia medical device approval

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
Obtained Vietnam MOH medical device approvals

Champion of the Intel AI Dev CUP x OpenVINO Toolkit Competition – Implementation Category
Obtained Singapore HSA medical device approval
Obtained TFDA medical device approval

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
Honored with the Chinese Trustworthy Brand Gold Award
Obtained U.S. FDA certification
Obtained Singapore HSA Class A medical device approval
Established ISO and QMS medical materials factory in Southern Taiwan Science Park
Founding of Biomedica