Introduction and Reflection on Novel Medical Device Regulatory Science Tool MDDT / 中国医疗器械杂志

In recent years, emerging technology medical devices have developed rapidly. How to more scientifically and more efficiently regulate these novel medical devices so as to improve access to advanced medical technology while ensuring safety and effectiveness is a new challenge faced by regulatory authorities, and is also the core topic of regulatory science. New tools, new standards and new methods are important means to achieve regulatory science. "Medical Device Development Tool" proposed by the U.S. FDA is a novel medical device regulatory science tool, which can help medical device developers to predict and evaluate product performance more efficiently. It is also helpful for regulatory authorities to make regulatory decisions more efficiently. This study introduces the concept, qualification process, role of MDDT in medical device regulation and MDDT examples, and makes some discussion on the device evaluation from the perspective of reliability and validity. MDDT can facilitate the developing of novel medical device.

Report on Cardiovascular Health and Diseases in China 2021: An Updated Summary / 生物医学与环境科学（英文）

In 2019, cardiovascular disease (CVD) accounted for 46.74% and 44.26% of all deaths in rural and urban areas, respectively. Two out of every five deaths were due to CVD. It is estimated that about 330 million patients suffer from CVD in China. The number of patients suffering from stroke, coronary heart disease, heart failure, pulmonary heart disease, atrial fibrillation, rheumatic heart disease, congenital heart disease, lower extremity artery disease and hypertension are 13.00 million, 11.39 million, 8.90 million, 5.00 million, 4.87 million, 2.50 million, 2.00 million, 45.30 million, and 245.00 million, respectively. Given that China is challenged by the dual pressures of population aging and steady rise in the prevalence of metabolic risk factors, the burden caused by CVD will continue to increase, which has set new requirements for CVD prevention and treatment and the allocation of medical resources in China. It is important to reduce the prevalence through primary prevention, increase the allocation of medical resources for CVD emergency and critical care, and provide rehabilitation services and secondary prevention to reduce the risk of recurrence, re-hospitalization and disability in CVD survivors. The number of people suffering from hypertension, dyslipidemia and diabetes in China has reached hundreds of millions. Since blood pressure, blood lipids, and blood glucose levels rise mostly insidiously, vascular disease or even serious events such as myocardial infarction and stroke often already occured at the time of detection in this population. Hence, more strategies and tasks should be taken to prevent risk factors such as hypertension, dyslipidemia, diabetes, obesity, and smoking, and more efforts should be made in the assessment of cardiovascular health status and the prevention, treatment, and research of early pathological changes.