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Recently, CH Biomedical, a technological pioneer in the global Ventricular Assist Device (VAD) field, successfully obtained ISO 13485:2016 certification from the authoritative third-party certifier BSI (Certificate No.: MD 758952). This achievement confirms that the company has achieved internationally standardized excellence across the design, development, manufacturing, and post-marketing quality management of its VAD products.
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May 24-27, 2022 International Society for Mechanical Circulatory Society (ISMCS) and European Mechanical Circulatory Society (EUMS) Joint Scientific Conference was successfully held in Hanover, Germany. Dr. Frank Lin, PhD, CTO of CH Biomedical, and Mr. Karl Nelson, Vice President of Clinical Operations were invited to attend the conference.
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Recently, at the 2022 China Medical Development Conference—widely regarded as the country’s premier medical forum—the Chinese Academy of Medical Sciences (CAMS) released two lists: China’s Major Medical Achievements of the 21st Century and China’s Important Medical Advancements in 2021. As a global innovator in the field of Ventricular Assist Devices (VADs), CH Biomedical’s independently developed CH-VAD (NMPA (A) 20213120987) was included in China’s Important Medical Advancements in 2021.
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On December 11, 2021, CH Biomedical officially launched its CH-VAD®, the implantable ventricular assist system (VAS) during the Critical Heart Disease Conference (CHDC). This milestone marks the beginning of commercialization for China’s first fully magnetically levitated VAD with complete independent intellectual property rights.
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On November 24th 2021, the implantable CH-VAD® left ventricular assist system (CH-VAD® LVAS) of CH Biomedical was approved by the National Medical Products Administration (NMPA) for marketing (Registration No.: GXZZ 20213120987). CH-VAD LVAS was developed independently by CH Biomedical, it is the first Left Ventricular Assist Device (LVAD) with complete independent intellectual property rights approved by NMPA in China, and the first full magnetic levitation LVAD approved by NMPA.
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From October 21 to 27, the “13th Five-Year Plan” Scientific and Technological Innovation Achievement Exhibition was held at the Beijing Exhibition Center. CH Biomedical’s CH-VAD, was showcased in the Social Development Section as a representative of China’s high-end medical devices.
