Recently, RainMed Medical Coronary Function Measurement System (hereinafter referred to as "RainMed caIMR") has successfully entered the special approval channel for innovative medical devices of NMPA, and has obtained the priority of NMPA certification. As the world's leading non-interventional microcirculation diagnosis system, the approval of caIMR fully reflects the international leadership of its technology and its superior clinical value.   The approval of the innovative application of caIMR will accelerate its commercialization, accelerate the opening of tens of billions of blue ocean market for microcirculation diagnosis, and lead the cardiovascular field into a new era of comprehensive assessment of myocardial functional ischemia. It also lays a key foundation for RainMed Medical to build a vascular interventional surgery robot covering the whole process of comprehensive diagnosis and treatment. Announcement of the review results of the special application for innovative medical devices   As a green channel for medical device approval, the special approval channel for innovative medical devices has a high approval threshold and a very low approval rate. Since the implementation of the approval process in 2014, only 170 products have been approved in China and the approval rate is only 20%. Among them, the caIMR and caFFR of RainMed and their supporting supplies have been successfully approved to enter the green channel of innovative medical devices, demonstrating RainMed Medical's excellent innovative R&D capabilities.   Preferential policy support and excellent clinical results jointly help RainMed to accelerate the commercialization of caIMR In the process of coronary heart disease diagnosis and treatment, IMR evaluation has important clinical significance and has been widely recommended by domestic and foreign guidelines. Data show that 40% of patients with coronary artery disease still suffer from recurrent angina after PCI, partly due to microcirculatory dysfunction. Therefore, guidelines such as "Guidelines for Diagnosis and Management of Chronic Coronary Syndrome", "Chinese Expert Consensus on Diagnosis and Treatment of Coronary Microvascular Diseases (2017)", "Chinese Multidisciplinary Expert Consensus on Diagnosis and Treatment of Microvascular Diseases (2020)" and other guidelines all recommend IMR assessment in patients with coronary heart disease. caIMR of RainMed caIMR of RainMed has made up for the deficiencies of traditional guide wire-derived IMR detection, and offered more practical clinical detection methods to coronary microcirculation. In the past, guide wire-derived IMR measurement requires the use of hyperemic agents and repeated injection of normal saline, which takes a long time to measure IMR and has a high risk and therefore it is only suitable for clinical research. caIMR does not require the pressure guide wire and hyperemic agents. It does not need to change the surgeon's surgical habits. It only takes an average of 5 minutes to measure IMR based on angiograms, blood flow velocity by TIMI frame count, real-time aortic pressure and a specially-designed CFD model. It is safe, efficient and simple, and offers a new opportunity to promote the large-scale clinical application of coronary microcirculation assessment.   As the world's first diagnostic method for coronary microcirculation function in the confirmatory clinical trial stage, RainMed caIMR was successfully approved to enter the green channel of innovative medical devices, bringing sufficient confidence to accelerate the large-scale clinical application of the product.   As of December 2021, RainMed caIMR has successfully completed the clinical enrollment of the confirmatory trial. The study is led by Zhongshan Hospital Affiliated to Fudan University with the top cardiology experts academician Ge Junbo and Professor Huo Yong of Peking University First Hospital as PI. At present, caIMR has achieved excellent clinical research results and has successfully entered the registration clinical stage. caIMR confirmatory clinical research launch ceremony The preferential policies and assistance to high-innovation medical devices given by the state and the confirmatory clinical results that exceeded expectations have brought more confidence to accelerate the commercialization of caIMR. It is believed that the large-scale clinical application of caIMR will surely improve the level of diagnosis and treatment of coronary artery disease and lead coronary artery disease into a new era of precision medicine.    Top SCI journals confirm that caIMR of RainMed has a wide range of clinical indications and excellent clinical application value The global initiative of RainMed caIMR has attracted extensive attention from well-known experts at home and abroad, and has become a hot topic of international clinical research. A number of blockbuster research papers published in SCI journals have made detailed demonstra

Recently, Dr. Chandan Deepak Bhavnani from Pusat Jantung Sarawak and president of National Heart Association of Malaysia Dr. Alan Yean Yip Dr Fong's team published results of a clinical trial using coronary angiography-derived fractional flow reserve measurement system caFFR. The paper was published in Journal of Asian Pacific Society of Cardiology (JAPSC). This was the first study of its kind in Southeast Asia. Based on previous trials, this trial advances the clinical significance of caFFR value for intermediate coronary artery stenosis. The results showed that caFFR had a good agreement with wire-based FFR. The 12-month outcomes showed that caFFR-guided deferral of PCI was safe and comparable to wired-based FFR guidance.

Recently, there is a bunch of good news in the field of medical device. A few days ago, the State Council executive meeting decided to use special re-loans and financial discount interest to support the renovation of equipment in some areas, increase market demand, and increase the development momentum. At the same time, the National Health Commission also issued a notice of upgrading medical device with financial discount loans. This policy will surely stimulate the vitality of hospital procurement and promote domestic innovative medical devices to grow with vigorous market vitality