Devices

FDA Expands Use of Dexcom Glucose Monitor

FDA has expanded the approved use of Dexcom’s G5 mobile continuous glucose monitoring system to allow for replacement of fingerstick blood glucose testing for diabetes treatment decisions in people age 2 and older who have diabetes, an agency media release says.

Dexcom’s is the first FDA-approved continuous glucose monitoring system that can be used to make diabetes treatment decisions without confirmation through a traditional fingerstick test. The system was previously approved to complement, not replace, fingerstick testing for diabetes treatment decisions.

The unit uses a small sensor wire inserted just below the skin that continuously measures and monitors glucose levels, FDA says. Real-time results are sent wirelessly every five minutes to a dedicated receiver and a compatible mobile device running a mobile app. The system measures glucose in fluid under the skin and must be calibrated at least two times per day using blood obtained from fingerstick tests.

FDA says it evaluated data from two clinical studies that included 130 adults and children age 2 and older with diabetes. All studies included a seven-day period in which system readings were compared to blood glucose meter values, as well as to a laboratory test that measures glucose values. No serious adverse events were reported during the studies, the agency said.

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