[Discussion on Technical Evaluation of Tongue Diagnosis Equipment of Traditional Chinese Medicine].

This study briefly introduces the tongue diagnostic equipment of traditional Chinese medicine. It analyzes and discusses the key points of technical evaluation of tongue diagnostic equipment from the aspects of product name, performance parameters, image processing functions, product use methods, clinical evaluation, etc. It analyzes the safety risks and effectiveness indicators of tongue diagnostic equipment, hoping to bring some help to the gradual standardization of tongue diagnostic equipment and the registration of enterprises.

[Approval Status and Suggestions on Supervision of Class II Innovative Medical Device].

Based on the current situation of approval and publicity of class II innovative medical devices in various provinces and cities, especially after analyzing the problems found in the review of class II innovative medical devices in Shanghai and the factors affecting the listing process of innovative medical devices, this study puts forward some thoughts on supervision for reference in establishing and perfecting systems and regulations, changing the review and approval thinking, extending services to the development of innovative medical devices and the formulation of clinical trial schemes.

[Discussion on Technical Evaluation of Enzyme Electrode Biosensor Blood Glucose Meter].

Enzyme electrode biosensor blood glucose detector is a new rapid blood glucose measurement method. There is no corresponding product standard and industry standard reference at home and abroad, and there is a lack of corresponding reference experience in performance research and clinical evaluation. This study discusses the safety and effectiveness of enzyme electrode biosensor blood glucose detector from the perspective of technical evaluation of medical devices.

A new radiation force balance method for measuring diverging piston source power in the frequency range 20-100 kHz: Theory and experimental verification.

The purpose of this work was to present the results of a theoretical and experimental study in which a new acoustic output power measurement method was developed for a strongly diverged ultrasonic beam (ka < 3, where k is the circular wave number and a is the radius of transducer) using acoustic radiation force. To the best of our knowledge, there is no acceptable and effective method to measure acoustic power P for diverging piston transducers from 20 kHz to 100 kHz in the range ka < 3, it is a unsolved problem acutely. In the study, we used radiation force balance (RFB) method with a novel concave semi-spherical absorbing target in far field to measure the acoustic power up to 54 W.

[Analysis on the development strategy for hearing aid fitting].

Based on the investigation and analysis of the current situation for hearing aid fitting, some analysis results and suggestions for the development of the industry are presented, including manufacturer, association for medical devices industry and supervision division.

[Discuss on risk management of medical device production and after-production].

By analysis on the risk management regulations and the situation of medical device after the product on the market, information list of problems and risk analysis process of the production and after-production were described, simultaneously, the suggestions were put forward to risk management after the product on the market, with the aim of providing reference for manufacturers and administrators.

Acoustic power measurement of high intensity focused ultrasound in medicine based on radiation force.

How to measure the acoustic power of HIFU is one of the most important tasks in its medical application. In the paper a whole series of formula for calculating the radiation force related to the acoustic power radiated by a single element focusing transducer and by the focusing transducer array were given. Various system of radiation force balance (RFB) to measure the acoustic power of HIFU in medicine were designed and applied in China.

Calibration of a focusing transducer and miniature hydrophone as well as acoustic power measurement based on free-field reciprocity in a spherically focused wave field.

The free-field transmitting voltage response at the pressure focus of a spherically focusing transducer was defined and calibrated based on the reciprocity theorem of a free-field spherically focused acoustic wave. The acoustic power, the radiation conductance, and the pressure at the pressure focus were derived and measured accordingly from the transmitting current response on the imaginary mirror symmetric spherical surface of the radiating surface. A miniature hydrophone was calibrated by the self-reciprocity of the spherically focusing source.