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Latest From Elizabeth Orr
In this week’s podcast, senior reporters Elizabeth Orr and Ferdous Al-Faruque give a quick rundown of FDA goings-on the device industry should keep a sharp eye on, including a reorganization of the Center for Devices and Radiological Health, remarks from outgoing agency head Scott Gottlieb on laboratory developed tests, and news from a recent FDA neurological devices advisory panel meeting.
The US FDA neurological devices panel on March 21 found significant faults with Neuronix’s de novo application for its neuroAD Alzheimer’s treatment system. A key concern was that the device missed its primary endpoint in the pivotal trial.
US FDA has updated a final guidance on the use of animal components in medical devices. The new version incorporates precautions intended to limit the transmission of a wider range of diseases, while the original focused on bovine spongiform encephalopathy (mad cow) disease.
New US FDA analysis of paclitaxel-coated devices to treat peripheral arterial disease matches previous reports of an increased death risk tied to use of the devices. The agency is encouraging providers to look to other treatment options while analysis continues.
US FDA's Center for Devices and Radiological Health will finally launch a long-planned reorganization that will see agency staff grouped by device types, rather than by stage in the device-review cycle. The reorganization begins this week and should be complete by Sept. 30.
4C Medical plans to conduct both an early feasibility study and the pivotal trial for its mitral regurgitation treatment device simultaneously in Japan, the US and Canada. The company says the study is the first early feasibility study in Japan for an implantable device.