Devices

Medical Device Prospective Active Surveillance Works: Study

An FDA-funded study reported in the New England Journal of Medicine says that a strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among recipients of an implantable vascular closure device. Initial reports occurred within the first 12 months of monitoring, the report says.

The study looked at the safety of the Cardinal Health Mynx vascular closure device when compared with alternative approved devices in percutaneous coronary intervention (PCI). “Our analysis showed a significantly higher risk of vascular complications, access-site bleeding, and transfusion requirement after PCI among patients treated with the Mynx vascular closure device than among those treated with alternative vascular closure devices, although the absolute risk differences were small,” the article says. “Among patients who received the Mynx device, alerts were triggered early, persisted throughout the duration of surveillance, and were present in all subgroups of patients. In addition, the primary results were confirmed in an independent, more contemporary cohort of patients.”

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