【Pharmaceutical Network Product InformationAccording to the review, since March, the National Medical Products Administration has approved the registration applications for 2 innovative medical device products produced in China, involving companies including Hangzhou Nuomao Medical Technology Co., Ltd. and Deepwise.
On March 11, according to the information on the website of the National Medical Products Administration, the registration application for the innovative product "Disposable Cardiac Pulsed Field Ablation Catheter" by Hangzhou Nuomao Medical Technology Co., Ltd. was approved.
The product consists of a catheter and connecting cable, and is used in conjunction with the cardiac pulsed field ablation system produced by Hangzhou Nuomao Medical Technology Co., Ltd. By controlling and delivering appropriately intense pulsed field energy, it selectively induces irreversible electroporation damage only to the myocardial cells in the targeted lesion area, thereby achieving the purpose of treating atrial fibrillation. This product provides more options for the treatment of drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.
Data shows that Nuomao (formerly known as Hangzhou Nuomao Medical Technology Co., Ltd.) is an innovative medical enterprise under the Denovo Medtech group. It focuses on the research, development, manufacturing, sales, and technical support of interventional medical devices for atrial fibrillation electrophysiology and stroke prevention. Its main products include electrophysiological devices for treating cardiac atrial fibrillation and interventional medical devices for stroke prevention, such as left atrial appendage closure devices.
Moreover, according to the information on the website of the National Medical Products Administration on March 1, the registration application for the innovative product "Deepwise Intracranial Aneurysm CT Angiography Image Auxiliary Detection Software" developed by Hangzhou Deepwise Technology Co., Ltd. has been approved.
Data shows that the product consists of software installation programs, including both browser-side and server-side components. It is used for the display, processing, measurement, and analysis of CT angiography images of the head and neck arteries and assists in detecting intracranial aneurysms of 3mm or larger. The product utilizes centerline extraction and vascular segmentation technology of the head and neck vessels, significantly improving the sensitivity of detecting intracranial aneurysms. It is of great significance for enhancing patients' quality of life and increasing their survival rate.
Deepwise is an artificial intelligence medical application developer, mainly covering areas such as medical imaging image recognition, early screening of various malignant diseases, and precise diagnostic solutions, particularly providing intelligent solutions for the entire process of early cancer detection, analysis, and follow-up.
According to reports, in recent years, supported by favorable national policies, innovative medical device products in China have been emerging one after another. Industry experts state that the technological advancements in medical devices have brought significant benefits to clinical practice. They have improved diagnostic accuracy, treatment methods, and patient safety, promoted personalized treatment and telemedicine, and advanced medical research and education. With the continuous development of technology, it is expected that medical devices will continue to bring more innovations to the healthcare field, enhancing the level of human healthcare.
Other experts pointed out that the scientific and technological innovation of domestically produced innovative medical devices is crucial to the long-term development of China's medical device industry. They suggested increasing financial investment in the innovative medical device industry by establishing special industry funds. Support should be given to innovative enterprises with good development prospects, especially those focusing on key technologies, important raw materials, and core components. Greater fiscal funding should be provided to promote R&D efforts, concentrating resources to overcome bottlenecks restricting the high-quality development of the industrial chain. Continuous advancement in key areas and iterative innovation of core components are essential for achieving balanced and robust growth of the industrial chain.
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