Devices

Argo Not Complying with ReWalk PS Plan: FDA

FDA says that Argo Medical Technologies has not complied with an agency 6/26/16 order to conduct post-market surveillance (PS) of its ReWalk medical device. A just-released 9/30/15 Warning Letter says the order was issued because the device’s failure to prevent a fall would be reasonably likely to cause serious injury and/or death through fall-related issues such as traumatic brain injury, spinal cord injury, and fractures to the user. The letter details many instances in which the company delayed responding to FDA or failed to meet its obligations under the order. Specifically, the letter says that Argo has:
failed to submit a revised PS study plan that adequately addresses the deficiencies described in an FDA 9/29/14 letter and the deficiencies described in the agency’s 2/13/15 letter; failed to design a PS study plan that answers the questions identified in the order; failed to have an approved PS study plan; and failed to begin surveillance not later than 15 months after the date that the order was issued.

Failure to meet these requirements means that the device is misbranded, the letter says.The company was told to take prompt action to correct the violations and to respond with a post-market surveillance study plan that addresses the deficiencies in the agency letters. Argo also was told to indicate steps taken to correct and prevent recurrence of the violations with documentation for each step and a timetable for completion.

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