Devices

FDA Approves Medtronic’s ‘Artificial Pancreas’

FDA has approved Medtronic’s MiniMed 670G hybrid closed looped system, the first agency-approved device that is intended to automatically monitor glucose and provide appropriate basal insulin doses in people 14 years of age and older with Type 1 diabetes. “The MiniMed 670G hybrid closed looped system, often referred to as an ‘artificial pancreas,’ is intended to adjust insulin levels with little or no input from the user,” an FDA release says. “It works by measuring glucose levels every five minutes and automatically administering or withholding insulin. The system includes a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump strapped to the body; and an infusion patch connected to the pump with a catheter that delivers insulin. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate (meal) consumption.”

Approval was based on clinical trial data from 123 patients with Type 1 diabetes. The clinical trial included an initial two-week period where the device’s hybrid closed loop feature was not used, followed by a three-month study during which trial participants used the feature as frequently as possible. No serious adverse events, diabetic ketoacidosis or severe hypoglycemia were reported during the study, GFA says.

As a condition of approval, the agency is requiring a post-market study to better understand how the device performs in real-world settings. Medtronic is currently performing clinical studies to evaluate the device’s safety and effectiveness in diabetic children aged 7-13 years.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome