This BAA is providing core program support to develop key capabilities of the Medical Device Plug-and-Play (MD PnP) Interoperability Program to lead medical device interoperability to support clinical solutions for improving patient safety and healthcare efficiency. Under MD PnP program leadership during the past year, a multi-institutional/industry working group submitted to FDA a Pre-IDE regulatory submission of a safe integrated medical device system; an updated version of the MD FIRE procurement language was signed by the VA and posted on our public website; the Clinical Landscape & Needs subgroup of the newly formed and FDA-sponsored Medical Device Interoperability Coordinating Council collected and shared clinical scenarios; we contributed materially to UL s proposed standard for certifiable safety of medical device interfaces; we collaborated with the VA, NIST, NSF, ONC, and others, including work with AAMI on standards and smart alarms initiatives.

关键词：医疗设备；随插即用；标准

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This guidance is intended to alert manufacturers of active pharmaceutical ingredients (APIs), pharmaceutical and medical device manufacturers of finished products, repackers, and others to the potential risk of crude heparin contamination. This guidance provides recommendations that will help API manufacturers, pharmaceutical and medical device manufacturers of finished products, repackers, and others, to better prevent the use of crude heparin that might contain over-sulfated chondroitin sulfate (OSCS) or non-porcine ruminant material contaminants

关键词：医疗设备；肝素药品；行业指南

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The Food and Drug Administration (FDA) plays a critical role in ensuring the safety and effectiveness of medical devices and other products. At the Center for Devices and Radiological Health (CDRH), a series of scientific disagreements received media attention between 2008 and 2010. In these instances, CDRH reviewers and their managers disagreed over whether medical devices under review met applicable review standards. In October 2009, CDRH issued new policies and procedures for resolving internal scientific disagreements related to regulatory decisions

关键词：医疗设备；监管；科学分歧

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关键词：医疗器械；微创外科手术/程序；心血管疾病；微创心血管手术；旋切术；血栓切除设备

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DBT is a 3D imaging technique used in detecting breast cancer. The DBT device captures images of thin slices of a stationary compressed breast at multiple angles during a short scan. After the scan, the images are reconstructed using algorithms into a series of thin high-resolution slices whose planes are parallel to the breast support plates. Tomosynthesis differs from computed tomography because the range of angles used is less than 360?. DBT provides several advantages and enhances the quality of the medical services available to patients. It minimizes recall rates, requires less compression of the breast, reduces tissue overlap in images, and provides efficient diagnosis of small tumors and skin lesions.

关键词：DBT；医疗设备；医疗器械；检测；乳腺癌；3D成像技术；设备捕获薄片；影像；小肿瘤；皮肤损伤

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Available to synthetic biologists are a wide range of genetic devices. Many of these devices are able to either sense or alter local conditions. The ability to sense a multitude of inputs combined with diverse outputs could enable engineered organisms that interact with their environment in new and complex ways. Currently the complexity of such systems has been limited by our ability to integrate several inputs into a desired output.Simple combinational logic functions, containing 1 to 3 logic gates, have been constructed in Escherichia coli, but more complex logic networks are needed to fully exploit the opportunities presented by these sensors and actuators. Use of genetic logic gates is constrained by the specific molecular interactions that are used to implement each gate. These interactions involve diffusible molecules that can move within the cytoplasm of the cell and therefore are not spatially separated from other gates. To make larger logic blocks, sets of gates that use unique molecular interactions with minimal crosstalk are required.

关键词：组合逻辑；大肠杆菌；可伸缩；医疗器械

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改革指引投资预期：十八届三中全会指向渐进式的改革，旨在控制风险、激活经济，而非破坏性的重建。国内投资增速下行缓慢：013年以来，我国城镇固定资产投资增速保持在20%左右，但新开工项目计划总投资增速仅为14.3%，预示着2014年投资增速仍将缓慢回落。海外经济运行平稳。机械产品需求企稳，部分行业产能有所去化。

关键词：工程机械；造船；船舶；铁路

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关键词：研发；智能；捞油机

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本报告关注点：前三季度机械行业整体业绩较为低迷；自上而下，关注油气钻采设备、铁路设备和航天军工板块，回避工程机械、矿山机械、重型机械、船舶等强周期行业；自下而上，关注部分业绩优异，成长性良好的个股。投资要点：机械行业上市公司业绩持续低迷。行业整体处于景气低谷，深入发掘成长性较好细分板块。风险提示：注意国内基建、房地产等固定资产投资增速下滑的风险；国际经济环境不确定性风险。

关键词：机械；铁路设备；石油钻采设备；能源化工设备；航天军工

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Machine safeguarding solutions are safety devices that reduce the potential risk that may arise due to faulty operation of a machine in a workplace or on a production line. They are aimed at developing a safe working environment for enhanced productivity. Thus, these solutions enable risk-free and safe applications such as assembly and disassembly, pressing, molding, fabrication, stamping, and forming. These solutions are used across industries including Automotive, Food and Beverages, Machine Building, Wood Working, Electrical and Electronics, Plastic, Textile, and other engineering industries.

关键词：机器保护；解决方案；安全装置；生产线；操作失误

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