Beijing Hanvon Health Technology Co., Ltd. (Hanvon Healthcare), a wholly owned subsidiary of Hanvon Technology, has announced that its AI-powered Korotkoff sound electronic blood pressure monitor has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA). This milestone follows the product’s successful medical device registration in China and marks a pivotal step in the company’s global expansion into the international healthcare market.

    Engineered with clinical precision, the innovative device integrates the classic clinical principle of Korotkoff sound-based blood pressure measurement with automatic operational functions and AI-enhanced signal recognition technology. Leveraging its long-standing expertise in pattern recognition and artificial intelligence, Hanvon Technology independently developed this cutting-edge blood pressure monitoring product to address the limitations of conventional monitoring devices.

    Traditional oscillometric blood pressure monitors calculate systolic and diastolic blood pressure values solely through waveform analysis, which delivers indirect estimated results. In contrast, Hanvon’s newly cleared device adopts authentic Korotkoff sounds as the core measurement basis, enabling more accurate, direct, and traceable blood pressure readings that align better with clinical diagnostic standards.

    Throughout the rigorous FDA review process, Hanvon Healthcare collaborated closely with the Shenzhen Academy of Metrology and Quality Inspection as well as the National Medical Device Industry Metrology and Testing Center. The joint efforts ensured full compliance with stringent international standards covering product performance, electrical safety, electromagnetic compatibility, and other critical regulatory requirements.

    The official FDA 510(k) clearance grants Hanvon Healthcare formal market access to the United States, laying a solid foundation for the company’s global strategic layout in digital healthcare and professional blood pressure management. Moving forward, Hanvon healthcare will continue to invest heavily in innovative blood pressure measurement technologies and develop high-performance, intelligent healthcare products to serve users worldwide.