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Vitae Biomedical Engages Clinical Community and Advances Regulatory Alignment at National Medical Device Forum
2025-10-16
Vitae Biomedical Co., Ltd. was invited to participate in the “2025 Innovative Niche Medical Device Clinical Exchange Forum,” where the company presented the latest progress of its urine-based lung cancer detection platform to healthcare professionals and industry stakeholders.

Held during the Taiwan Innotech Expo, the event brought together medical institutions, device companies, and innovation teams to explore clinical applications and emerging technologies. Vitae Biomedical’s non-invasive diagnostic platform attracted attention for its ability to integrate into existing clinical workflows, offering a practical approach to improving early lung cancer risk detection.

During the session, the company shared updates on its technology development, ongoing clinical collaborations with hospitals, and strategies to enhance clinical adoption through cost efficiency, workflow integration, and ease of use. The discussions reflected strong interest from the medical community in accessible and patient-friendly screening solutions.

In addition, representatives from British Standards Institution (BSI) engaged with the company regarding regulatory pathways under the European In Vitro Diagnostic Regulation (IVDR). The dialogue included potential transition planning from existing CE (IVDD) certification and alignment with the more stringent IVDR framework, which is expected to further strengthen the company’s competitiveness in global markets.

Participation in the forum highlights Vitae Biomedical’s ongoing efforts to connect technological innovation with clinical practice and regulatory development. By aligning clinical engagement with international compliance strategies, the company continues to advance toward broader adoption of non-invasive diagnostic solutions worldwide.
 
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