Devices

Glucose Meter Benefits Outweigh Risks Panel Says

At the 3/30 meeting of the FDA Clinical Chemistry and Clinical Toxicology Devices Advisory Panel, members indicated that the benefits of using glucose meters for measuring blood glucose in capillary blood in patients receiving intensive medical intervention/therapy outweigh the risks. The comment came in response to FDA’s request for an opinion on the benefits and risks of measuring capillary blood using blood glucose meters in patients receiving intensive medical intervention or therapy and the considerations for CLIA waiver for this use.

Panel members said they recognized that there are many clinical conditions such as hypothermia, hypotension, shock, edema, etc., in which capillary blood testing may be problematic. Potential risk mitigation strategies discussed included increased training of medical personnel using point-of-care testing and quality control programs.

Panel members also said that a major issue was the quality of the capillary blood sample being assessed by the blood glucose meter rather than the meter itself. There was no consensus as to whether modifications of the current CLIA status of blood glucose meters in the hospital setting would address the issue. Panelists commented both in favor of and against maintaining a CLIA waiver for using glucose meters for measuring blood glucose in capillary blood in patients receiving intensive medical intervention/therapy.

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