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U.S. Food and Drug Administration  留言于2018-08-09 07:11:51 |
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评论：UPDATE - From The Chinese American Professors and Professionals Network (2018 No.19) |
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FDA has recently approved the following devices to be marketed:
Zephyr® Endobronchial Valve System - P180002
The Zephyr Endobrochial Valve System is an implantable bronchial valve used to reduce over inflation of the lungs due to severe emphysema in adults. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane.
Eversense Continuous Glucose Montioring System - P160048
The Eversense Continuous Glucose Monitoring System, is a prescription device that provides real-time glucose monitoring every five minutes for up to 90 days at a time for people with diabetes. The system consists of an implantable fluorescence-based sensor, a smart transmitter, and a mobile app for displaying glucose values, trends and alerts on the patient''''s compatible mobile device (smart phone, tablet, etc.).
Minimed 670G System - P160017/S031
The Medtronic MiniMed 670G System is the first FDA approved hybrid closed loop system that monitors glucose and automatically adjusts the delivery of long acting or basal insulin based on the user''''s glucose reading in users seven years of age years and older. This device was approved on September 28, 2016 under P160017 for users aged 14 years and older.
Freestyle Libre 14 Day Flash Glucose Monitoring System - P160030/S017
The Freestyle Libre 14 Day Flash Glucose Monitoring System (Freestyle Libre) is a glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without obtaining a blood sample from the fingertip (fingerstick). The system consists of an externally-worn glucose sensor that continuously measures glucose levels and displays values to the user in response to a user-initiated action (scan). This supplement updates the FreeStyle Libre''''s approval to provide on-demand glucose information to a user for up to fourteen days (the life of each sensor). The system does not passively monitor glucose levels or provide messages, alarms or alerts in the absence of user-intiated action.
Magtrace and Sentimag Magnetic Localization System - P160053
The Magtrace and Sentimag Magnetic Localization System is a magnetic device system used to guide lymph node biopsies in patients who are undergoing mastectomy for breast cancer. The system is a combination product that includes the Magtrace injectable magnetic tracer (a drug and a device), and the Sentimag magnetic sensing probe and base unit (device). The system assists in sentinel lymph node biopsies, which are used to determine whether the cancer has spread beyond the initial tumor into the lymph nodes, by identifying the lymph nodes draining a tumor site.
Surpass Streamline Flow Diverter - P170024
The Surpass Streamline Flow Diverter is a cobalt chromium and platinum tungsten braided, self-expandable tube (stent) intended for the treatment of wide-neck and fusiform intracranial aneurysms.
t:slim X2 Insulin Pump with Basal-IQ Technology - P180008
The t:slim X2 Insulin Pump with Basal-IQ Technology (the System) consists of a continuous glucose monitor (CGM) and an insulin pump with Basal-IQ technology. The System is intended to monitor glucose (sugar) levels and to deliver insulin for the management of diabetes. The Basal IQ technology feature of the insulin pump predicts whether glucose levels will fall below a predefined threshold to suspend insulin delivery. Diabetes is a disease in which your blood sugar or blood glucose levels can go too low or too high. |
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Amanda 留言于2018-08-02 16:00:16 |
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评论：CSSA-UCLA 猴年春晚（1/30） |
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Dear Mr/Mis,
我们是Protheragen Inc. (www.protheragen.com) ，目前在中美两国大力招聘优秀硕士、博士人才，因此给您发信，希望能够获得贵校的CSSA mailing list，这样我们的HR可以将招聘信息发送到贵校的同胞手中。
以下是我们的部分招聘信息：
Protheragen Inc.成立于2005年，是一家以化学制药和生物技术开发为主的制药服务公司，服务范围贯穿从药物发现到临床实验的全过程。现因业务扩大需要，在北京、天津、西安、成都、上海和美国纽约招聘以下岗位：
1. Senior Scientist, Cell & Gene Therapy
博士或者硕士学历，5年相关科研经历，海外背景候选人可放宽要求。
2. Scientist, PK/PD and PBPK Modeling
博士或者硕士，至少5年相关科研经历，海外背景候选人可放宽要求。
3. Principal Scientist, Immuno-oncology, Cancer Vaccines & Immunotherapeutics
要求5年以上实验室工作经验，英语熟练，海外背景候选人可放宽要求。
4. Senior Scientist, Cancer Immunology
博士，至少2年工业界研发经验，海外背景候选人可放宽要求。
5. Project Manager
生物、有机化学硕士或者博士，有5年以上工业界或者学术界相关研发经历，英语流利。
6. Principle Scientist, Enzymology
博士或者硕士拥有超过3年的相关科研工作经历，英语流利。
7. Business Development, Animal Disease Models
硕士及以上学历，英语流利，有3年以上相关工作经验者优先。
8. Technical Account Manager
硕士，英语流利，有海外背景优先。
9. Senior Scientist in Antibody
博士或者硕士拥有3年以上工作经验。
10. 化药合成研发总监
博士或者硕士，拥有8年以上相关研发经验，海外背景候选人可放宽要求。
招聘要求：
生物、有机化学、分析化学、基础医学和药学相关背景硕士、博士应届生及往届人才。
我们的招聘岗位包括但不限于以上岗位，具体的职位和要求可以详细交流。
薪酬福利：
国内优秀员工将有美国进修与工作机会，可以支持办理工作签证；美国工作人员可提供工作签证和绿卡支持。
硕士在美国工作年薪在6万美元以上，博士年薪10万美元以上。
国内工作待遇依据不同城市而不同。
薪资构成：基本工资+岗位津贴+项目提成+绩效+年终奖+其他福利奖金
急切期待您的回复，我们会以饱满的热情等待每一位新同事的到来！
联系方式：
Email: recruit@protheragen.com
祝好 |
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U.S. Food and Drug Administration 留言于2018-07-28 02:10:58 |
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评论：UPDATE - From The Chinese American Professors and Professionals Network (2018 No.18) |
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FDA has recently approved the following devices to be marketed:
iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) - P170043
The iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) consists of two small titanium stents (tiny tubes) that are pre-loaded into a stent delivery tool (Model G2-M-IS injector). During cataract surgery (surgery to remove the natural lens that has become cloudy and caused significant vision loss), these stents are implanted into the eye of patients with primary open angle glaucoma (POAG) to help drain fluid that has built up.
enVista® One Piece Hydrophobic Acrylic Toric Intraocular Lens - P910056/S027
The enVista® One-Piece Hydrophobic Acrylic Toric Intraocular Lens, Model MX60T is an artificial lens (Intraocular lens, IOL) implanted in the eye of adult patients for visual correction following the removal of a cataractous lens. Cataracts are often the result of aging, but can have other causes. The enVista MX60T IOL is a toric lens shaped differently from a standard spherical lens, and is intended to correct blurred vision due to an irregularly shaped cornea (astigmatism). This approval adds a new indication to specify that the enVista IOL is approved for use with the Medicel ACCUJECT 2.6-1P injector set, or other injector sets that specifically identify the enVista MX60T lens in the FDA-cleared labeling.
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