Cardiac Biotech Solutions Advances MyCardia AT Cardiac Monitor Toward China Market Entry with NMPA Submission
核心洞察
Cardiac Biotech Solutions (搜索) has initiated manufacturing and regulatory preparation activities in China for its MyCardia AT (搜索) cardiac event monitoring device through partnership with licensed NMPA manufacturer Ebulent Medical (搜索).
The company has delivered printed circuit assemblies and components to Ebulent in Shenzhen, with an initial manufacturing run scheduled for completion by month-end for required in-hospital clinical field testing.
Following successful device validation in hospital use, the final regulatory dossier will be submitted to the NMPA advisory board for commercial clearance of the MyCardia AT (搜索) device in China.
Cardiac Biotech Solutions (搜索), Inc. (OTCID: CBSC) has formally initiated manufacturing and regulatory preparation activities in China for its MyCardia AT (搜索) cardiac event monitoring device, marking a significant step toward entering the Chinese healthcare market. The company announced on January 15, 2026, that it has partnered with Ebulent Medical (搜索) (Shenzhen) Ltd., a licensed National Medical Products Administration (NMPA) medical device manufacturer, to advance the regulatory approval process.
Manufacturing Pipeline Activation
CBSC has recently delivered printed circuit assemblies, components, and accessories for the MyCardia AT (搜索) system to Ebulent's Shenzhen facility. A secure cloud-based data room containing the complete manufacturing package has been activated, including bills of materials, assembly instructions, validation software, testing protocols, and packaging documentation. Ebulent is using this comprehensive package to build its NMPA-compliant manufacturing file and Device History File (DHF).
Ebulent has begun configuring its production line and post-assembly validation stations for the MyCardia AT (搜索) device and is scheduled to complete an initial manufacturing run by month-end. These manufactured devices will be placed into active hospital accounts in China for required in-hospital clinical field testing, building on the company's existing clinical trial that has recently topped five million prior patient procedures.
Regulatory Pathway to Market
Following successful device validation in hospital use, Ebulent will register as CBSC's Chinese manufacturing partner with the NMPA. Since Ebulent is already an NMPA-approved medical device manufacturer, the registration process is expected to be a filing-based formality. CBSC, Ebulent, and CBSC's Chinese clinical partners will then submit the final regulatory dossier to the NMPA advisory board for commercial clearance of the MyCardia AT (搜索) device in China.
"This partnership gives us direct access to a fully licensed Chinese medical-device manufacturing and regulatory infrastructure," said Charles Martin, Chief Executive Officer of CBSC. "We believe that Ebulent's scale, quality systems, and regulatory standing significantly strengthen our ability to achieve NMPA clearance and commercialize MyCardia AT (搜索) in China."
Technology and Revenue Model
The MyCardia AT (搜索) integrates lightweight, easy-to-use wearable technology with AWS Cloud-based connectivity and mobile applications for iOS, Android, and WeChat platforms. The device produces a recurring revenue stream for the company through a revenue-sharing model that varies by market, reflecting regional healthcare economics and reimbursement practices.
Strategic Expansion Context
This China initiative represents another significant milestone in CBSC's mission to provide cardiac monitoring solutions worldwide and builds on the company's recent international expansion, including regulatory approval in Canada and exclusive distribution agreements in Central and South America.
Cardiac Biotech Solutions (搜索) provides innovative products and services in the ambulatory non-invasive cardiac monitoring space through its international subsidiaries. The company's electrocardiogram (EKG) devices, interactive cloud-based acquisition software, and smartphone apps for both iOS and Android platforms are designed to provide improved compliance for patients at risk of abnormal heart rhythms and more accurate information for physicians.
Ebulent Medical (搜索) (Shenzhen) Ltd. operates through its Shenzhen and Huizhou facilities, providing comprehensive contract development, regulatory, and manufacturing services for medical device companies. Its integrated R&D, quality systems, regulatory registration support, and advanced production capabilities enable the design, validation, and commercial manufacture of regulated medical devices for the Chinese and global healthcare markets.