Devices

‘Corrective Recall’ Asked for Hemodialysis Units

A 1/20 citizen petition submitted by the Service Employees International Union — United Healthcare Workers West calls on FDA to issue a “corrective recall” requiring modifications to specific hemodialysis machines manufactured by Fresenius USA. The petition asks that FDA require:

a modification to include an ultrafiltration settings screen that calculates a patient’s ultrafiltration rate in a specified manner and displays the result of that calculation throughout the hemodialysis session;
a modification to include a distinctive alarm when the ultrafiltration rate exceeds the specified level;
a relabeling requirement to include a Boxed Warning with specified language indicating that an ultrafiltration rate above the specified level is associated with an increased risk of death;
a relabeling requirement for labeling to include disinfection procedures for the hemodialysis machines as proposed by the union; and
a modification to the Conductivity Alarm Position setting in the Dialysate Screen to allow a locked setting that would prevent adjustment of the Conductivity Alarm Window during treatment.

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