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.

Clinical observation of scalp acupuncture plus speech rehabilitation for Broca's aphasia after cerebral stroke / 针灸推拿医学（英文版）

Objective:To explore the clinical efficacy of scalp acupuncture plus speech rehabilitation in treating Broca's aphasia after cerebral stroke, for providing novel evidences for the treatment. Methods:Ninety-one eligible patients with Broca's aphasia after cerebral stroke were randomized into an observation group and a control group. Forty-six cases in the observation group were intervened by scalp acupuncture plus speech rehabilitation, while 45 cases in the control group were treated by speech rehabilitation alone. The aphasia battery of Chinese (ABC) and Boston diagnostic aphasia examination (BDAE) were adopted to evaluate the clinical efficacy. Results:After the treatment, the scores of oral expression, reading and writing and global score in the observation group were significantly higher than those in the control group (allP<0.05). There was a significant difference in comparing the BDAE grading between the two groups after the treatment (P<0.05). After intervention, the basically-recovered plus markedly-effective rate was 45.7% in the observation group versus 24.4% in the control group, and the between-group difference was statistically significant (P<0.05). Conclusion:Scalp acupuncture plus speech rehabilitation is effective in treating Broca's aphasia after cerebral stroke, and worth promoting.