Clinical Trials Sought For Atherectomy Device 510(k)s In FDA Guidance
New US FDA draft guidance on 510(k)s for peripheral vascular atherectomy devices asks sponsors to submit clinical trial data due to lack of a good animal model.
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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.
Medtronic’s MiniMed 600 series of insulin pumps is the subject of a high-risk class I recall because a component may break, leading to over- or under-dosing of insulin. The company warned patients of the issue last November.