Devices

Newborn Test for Duchenne’s Cleared for Use

FDA has authorized the de novo marketing of PerkinElmer’s GSP Neonatal Creatine Kinase-MM kit as an aid in newborn screening for Duchenne Muscular Dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness. Newborn screening uses a small amount of blood from an infant’s heel to test for a variety of diseases and conditions. The de novo authorization enables laboratories to add the GSP Neonatal test to their newborn screening panel if they choose to do so, the agency says in a release, adding that there is currently no recommendation to do that routinely.

The GSP test works by measuring the concentration of a type of protein called CK-MM, which is part of a group of proteins called creatine kinase, FDA says. “Creatine kinase is found in muscle tissue and CK-MM enters the blood stream in increased amounts when there is muscle damage,” it explains. “This test measures the levels of CK-MM from the dried blood samples collected from the prick of a newborn's heel 24 to 48 hours after birth. Elevated levels of CK-MM detected by the kit may indicate presence of DMD. Results showing elevated CK-MM must be confirmed using other testing methods, such as muscle biopsies, genetic and other laboratory tests.”

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