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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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