[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.

Delocalized photonic deep learning on the internet's edge.

Advanced machine learning models are currently impossible to run on edge devices such as smart sensors and unmanned aerial vehicles owing to constraints on power, processing, and memory. We introduce an approach to machine learning inference based on delocalized analog processing across networks. In this approach, named Netcast, cloud-based "smart transceivers" stream weight data to edge devices, enabling ultraefficient photonic inference.

[Regulation Considerations of Medical Devices with Wireless Technology].

Wireless technology has been widely used in medical devices and has brought convenience to medical care. However, wireless medical devices face risks such as data security and radio frequency interference. This study highlights safety and effectiveness evaluation of wireless medical devices, and discusses technical characteristics and regulation requirements, providing references for industry development and regulation.

Optical spectrum feature analysis and recognition for optical network security with machine learning.

Physical layer attacks threaten services transmitted through optical networks. To detect attacks, we present an investigation of optical spectrum feature analysis (OSFA) and recognition. By analyzing the spectral features of optical signals, recognition and detection of unauthorized signals can be realized.

[Status Analysis and Improvement Suggestions on the Renew Registration of Passive Medical Devices].

The article collected 250 renew registration of domestic Class Ⅱ passive medical devices from Jan. 2016 to Aug. 2017 in Shanghai.

[Instruction of the technical evaluation for medical devices kits].

Recent years, the development of medical devices kits is rapid. How to make the technical evaluation of medical devices kits more perfect bases on the two major principles of safe and effective, and to make kits in the market more normative and orderly, these issues for technical evaluation have to be considered. This article makes a study on current situation of production, classification of management and registration status, combined with existing regulations and related standards, and discusses technical evaluation related issues.

Association of the expressions of platelet-derived growth factor receptor and c-Fos with the biological characteristics of bladder cancer.

Objective: To elucidate the relation of platelet-derived growth factor receptor (PDGFR) and c-Fos protein expressions with human bladder transitional epithelial cell carcinoma (BTCC).

Methods: The expressions of PDGFR and c-Fos were investigated in 11 normal bladder tissue samples, 14 adjacent non-carcinoma tissues and 43 BTCC tissues by means of SP immunohistochemical technique.

Results: The c-Fos expression was found in the cell nuclei and cytoplasm, and PDGFR in the nuclear membrane, cytoplasm, and cellular membrane.