Designing Trials For Devices Targeting Neuro-Disease Progression: An FDA Guide
The US agency finalized its guidance on IDEs for devices intended to treat the cause or progression, rather than just the symptoms, of neurological conditions like Alzheimer's.
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FDA issued a draft guidance to help device-makers conduct clinical trials for products designed to slow the progress of neurological conditions. One challenge highlighted by the agency is that changes to biomarkers measured in a study may not line up easily with disease progression.
FDA is soliciting nominations from developers of tools to facilitate more predictable, efficient, and transparent regulatory evaluation of devices under a pilot program announced Aug. 15
The US FDA has announced a high-risk class I recall on two makes of coronary dilation catheters made by Abbott Vascular because a manufacturing issue could lead to difficulties deflating the balloon. The catheters have been linked to 13 complaints and one death.