Devices

FDA, VA Collaborate to Accelerate Device Innovation

FDA says it will collaborate with the Veterans Health Administration on efforts to help accelerate American medical device innovation to further improve and benefit public health. An agency notice says the VA Ventures Innovation Institute in Seattle, WA, will host up to 12 FDA staff to foster robust collaboration between the two agencies.

The notice says the FDA staff will focus on the regulatory science, while the VA staff will provide a clinical context for test development and provide hands-on training and other immersive experiences for innovators wishing to use the tools.

The organizations will work toward developing and disseminating new tools designed to test the safety and effectiveness of medical devices and emerging technologies, the notice says. “These ‘off-the-shelf’ testing tools will provide innovators with straightforward, reproducible and cost-effective testing methods throughout the product development cycle,” FDA says. “Providing standardized tests can help streamline the regulatory evaluation process, accelerating the time it takes for products to reach patients by increasing predictability in the product development process. This effort may also reduce risks for early innovators that might not have access to more elaborate testing systems.”

FDA says the initial collaborative efforts with the VA will focus on interoperable systems that can exchange health information automatically for the diagnosis and treatment of patients. Future efforts will include the development of test methods for devices that can be used at a distance through, for example, 5G networks, it says.

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’

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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

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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