Sinocare Subsidiary’s “Multi-Series Smart Blood Pressure Monitors” Obtain U.S. FDA Certification

Recently, a series of smart blood pressure monitors developed by Dongguan E-Test Technology Co., Ltd., a subsidiary of Sinocare, successfully obtained the U.S. FDA 510(k) clearance. This achievement once again demonstrates Sinocare’s strong R&D capabilities and product quality in the field of smart medical devices, providing new momentum for the company’s global strategic expansion.

The FDA certification, known worldwide for its rigorous standards and authority, is regarded as one of the highest entry thresholds in the global medical device industry. For wireless medical monitoring products in particular, the FDA imposes stricter requirements on accuracy, safety, and reliability. The FDA 510(k) clearance awarded to Dongguan E-Test Technology confirms that its smart blood pressure monitors meet internationally advanced standards across multiple core metrics, granting them access to the mainstream U.S. medical market.

Hypertension, as one of the most common chronic diseases, is a major cause of cardiovascular and cerebrovascular disorders worldwide. Accurate and convenient blood pressure monitoring plays a critical role in disease management and prevention. Sinocare’s smart blood pressure monitor series integrates medical-grade accuracy, wireless data transmission, and intelligent alerts. In addition to one-touch measurement, users can synchronize data in real time via Bluetooth to a mobile application, enabling long-term trend tracking. These products are particularly suitable for home health monitoring as well as telemedicine scenarios.

As a global leader in diabetes digital management, Sinocare’s FDA certification further strengthens its chronic disease monitoring product portfolio and market competitiveness, laying a solid foundation for expanding into overseas markets including Europe and the United States.

Looking ahead, Sinocare will continue to advance its digital chronic disease management model of “biosensing + IoT + smart healthcare + lifestyle guidance,” building a closed-loop ecosystem from monitoring to management, and from hardware to services. By providing innovative and systematic smart healthcare solutions for chronic disease prevention and management, Sinocare will further enhance international compliance and local innovation, accelerating the global adoption of China’s smart medical products and health management solutions.