Devices

FDA Warning on NuVasive’s Precise Implants

FDA is warning health care providers about potential biocompatibility concerns associated with NuVasive Specialized Orthopedics’ Precice devices made from stainless steel and titanium. The implants are intended for people age 18 years and over to lengthen a limb, shorten or compress a limb, or transport segments of long bones.

An agency notice says it has received reports describing pain and changes in surrounding bone and soft tissue in patients with the stainless steel-based Precice devices. “These adverse events may be related to corrosion, wear, and previously unanticipated exposure of components that are undergoing biocompatibility testing,” it says. “At this time, the FDA is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices. As NuVasive continues to investigate the root cause of issues with stainless steel-based Precice devices, the company is also looking into how those issues may relate to titanium-based devices.”

In April, the company posted a statement informing health care providers of ongoing biocompatibility testing with Precice devices and placed a global ship hold for all Precice devices.

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