Devices

Petition Seeks Action Against MRI Accessories

A citizen petition from the law firm Wood, Herron & Evans urges FDA to detain Magnacoustics’s MagnaTouch MRI Music System, Genesis Ultra MRI Music System and MagnAlarm because they are not cleared by the agency under a 510(k). The petition says the devices are “clearly accessories to magnetic resonance diagnostic devices and remote medication management systems within the meaning of 21 CFR § 892.1000. Consequently, in the absence of device and establishment registration and pre-market notification as required under the Act, the MagnaTouch MRI Music System, Genesis Ultra MRI Music System and MagnAlarm devices are misbranded.” Based on research by the law firm, Magnacoustics has not successfully submitted evidence of substantial equivalence to FDA, which includes compliance with recognized consensus standards for such.

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