On May 29, 2024, the official website of the Center for Medical Device Evaluation of the National Medical Products Administration releasedApplication for Special Review of Innovative Medical DevicesReview Result Announcement (No. 5, 2024). June 13,Singular Medical's Implantable Cardiac Monitor (ICM) has passed the public announcement period and officially entered the special review process (also known as the "Green Channel"). This product is the first Implantable Cardiac Monitor (ICM) to enter the innovative special review process.
To enter the special review process for innovative medical devices, three basic conditions must be met:
(1) The applicant, through its leading technological innovation activities, legally owns the core technology invention patent rights of the product in China, or has legally obtained the invention patent rights or its usage rights in China through assignment. The application time for the special review of innovative medical devices is no more than 5 years from the patent authorization publication date; or the core technology invention patent application has been disclosed by the State Council's patent administration department and a search report has been issued by the Patent Search and Consultation Center of the National Intellectual Property Administration, which states that the core technical solution of the product possesses novelty and inventiveness.(2) The applicant has completed the preliminary research of the product and has a basically finalized product. The research process was genuine and controlled, and the research data is complete and traceable.(III) The product's main working principle or mechanism of action is a pioneering innovation in China, with fundamental improvements in performance or safety compared to similar products. It is at an internationally leading level technologically and has significant clinical application value.The introduction of the special review process for innovative medical devices and the establishment of an innovative approval channel will enhance interactions between review agencies and companies, and the prioritized approval process will also significantly accelerate product registration and market entry. Additionally, policies introduced by the central government and local governments across ChinaSystemList policies, and also provide a better development environment and guarantees for innovative products.Singular Medical believes that, with comprehensive technical reserves and production line support, the clinical application of domestically produced ICM is within reach. This will provide a localized solution for patients requiring long-term, precise ECG monitoring, while ensuring medical data remains within China. Singular Medical will continue to research, develop, and manufacture high-end medical devices in the field of arrhythmia, aligning with the trend of domestic substitution. Through professional, rigorous, and efficient services, we aim to give everyone lasting peace of mind.Singular Medical Implantable Cardiac Monitor (ICM)The implantable cardiac monitor (ICM) approved this time has full independent intellectual property rights, can accurately detect various arrhythmia ECG signals, and features a large ECG storage capacity.As the first ICM in China, the titanium alloy body exhibits excellent biocompatibility. It not only breaks through traditional ICM technical barriers and covers home monitoring but also is the first to be equipped with Bluetooth telemetry, supporting real-time cloud transmission via mobile phones and providing more timely diagnostic and treatment assistance. This ICM has successfully completed type inspection and animal experiments and has entered the clinical trial stage.Singular Medical is a leader in the research, development, and production of cardiac rhythm management medical devices in China, committed to creating high-end CRM medical devices for the Chinese market.The company's product line covers Implantable Cardioverter Defibrillators (ICD), Insertable Cardiac Monitors (ICM), CSP pacing systems, and external heart failure monitoring devices. The company has built an elite team consisting of experienced and technically proficient engineers and industry veterans, aiming to provide high-quality and convenient medical products and services to benefit more patients.In 2022, Singular Medical was rated by the U.S. Medtech Outlook magazine"Best Medical Technology Company in China 2022"，2023Selected"Forbes Asia 100 to Watch""Enterprise" list,The company's professional capabilities have gained international attention.Company ICD May 2024Product Honored"VBEF2024 Annual Innovative Products List in Healthcare Industry", IndustryBoundaryFully affirmed the outstanding contributions and remarkable achievements of Singular Medical in the medical field.Looking ahead, Singular Medical will take innovation, quality, and service as its core values, adhere to the concept of "patient-centeredness," continuously improve its technical and service levels, develop products required for CRM clinical use, and make outstanding contributions to the cause of human health.(Implantable ECG Event Monitor System Diagram)
