DAIKEN MEDICAL CO.,LTD. [7775.T]
TOKYO, Jun 17 (Pulse News Wire) – Daiken Medical CO.,LTD. (7775.T) updated investors on its progress toward obtaining European Union Medical Device Regulation (MDR) approval for its Codec Amy PCA product.
As previously disclosed on October 31, 2024, the technical documentation, biological safety, and sterility assurance reviews have been completed, leaving clinical evaluation as the primary remaining task. Currently, Daiken Medical is collaborating with external experts to finalize post-market clinical follow-up plans (PMCF) and prepare necessary application documents. While the exact timeline remains uncertain due to regulatory review processes, the company plans to file its MDR application within the current fiscal year.
In parallel, Daiken Medical is advancing regulatory filings in non-EU regions such as Vietnam and South America. The company aims to strategically expand Codec Amy PCA's global presence while adhering to local regulations. Looking ahead, Daiken Medical expects minimal impact on current earnings but views Codec Amy PCA as crucial for long-term growth.
Any significant developments will be promptly communicated to stakeholders.
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