01/15/2026
Cardiac Biotech Solutions, Inc. (OTCID: CBSC) has activated its China manufacturing and regulatory pathway for the MyCardia AT cardiac event monitoring platform.
Through its partnership with Ebulent Medical (Shenzhen) Ltd., an NMPA-licensed medical device manufacturer, the Company has initiated regulated manufacturing preparation, production line setup, and required hospital field trials. These activities support the final regulatory submission process for commercial clearance in China.
This development follows recent international milestones, including regulatory approval in Canada and exclusive distribution agreements in Central and South America. Together, these steps reflect CBSC’s methodical approach to global commercialization, leveraging established regulatory infrastructure and region-specific distribution partnerships.
The MyCardia AT platform combines wearable cardiac monitoring with cloud-based connectivity and mobile applications, supporting a recurring revenue model aligned with regional healthcare economics.
The Company will provide additional updates as regulatory and commercialization milestones are completed.
Learn More: https://cardiacbiotech.com/cardiac-biotech-solutions-activates-china-production-pipeline-for-mycardia-at-and-moves-into-final-nmpa-submission-phase/
Cardiac Biotech Solutions (CBSC) activates China manufacturing with Ebulent Medical and enters final NMPA submission phase for MyCardia AT.
