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Pocket controller for HeartMate II approved

Thoratec Corporation (Pleasanton, CA) received FDA approval to market the HeartMate II Pocket Controller, a small, safe "face" of the HeartMate II left ventricular assist device (LVAD) system. The Pocket Controller is designed to support active patients using the HeartMate II LVADs. The Pocket Controller is lighter and more compact than previous LVAD system controllers, and it features an intuitive user interface with enhanced information content.


Additionally, with a single-side cable design, the device can slide easily into a front pocket. The controller's patient safety features include prioritized visual alarms, on-screen instructions, and a backup battery that can provide at least 15 minutes of full power during periods of inadvertent disconnections from power sources.

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First hemoglobin A1C test for diagnosing diabetes

The FDA approved the COBAS INTEGRA 800 Tina-quant HbA1cDx assay (Roche Diagnostics, Basel, Switzerland) for the diagnosis of diabetes. It is the first hemoglobin A1C (A1c) test the agency has approved for this use.


The A1c tests currently on the market are approved for monitoring patients' blood glucose control but not for diagnosing diabetes.


The FDA analyzed 141 blood samples and found less than a 6% difference in the accuracy of test results from the Tina-quant HbA1cDx assay compared with results from the standard reference for hemoglobin analysis.


The Tina-quant HbA1cDx assay should not be used to diagnose diabetes during pregnancy, should not be used to monitor diabetes in patients with severe chronic, hepatic, or kidney disease, or those with hemoglobinopathy, hereditary spherocytosis, or malignancies. The test also should not be used to diagnose or monitor diabetes in patients with the hemoglobin variant hemoglobin F.