Recall Of Valiant Navion Could Cost Medtronic $40M
The company ordered the recall after three stent fractures and a death occurred in an 89-participant clinical trial.
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Results Recap is Medtech Insight's exclusive summary of clinical trial results that have been announced or published in the past week, based on information collected by Meddevicetracker. This week's edition covers the week of Oct. 19 - Oct. 25, including trial announcements from Medtronic, iCAD, PharmaEngine, Inc., Nanobiotix SA, and Myriad Genetics.
The US agency’s safety alert says the devices, which measure blood oxygen levels, may be less accurate in patients with darker skin tones.
The program will be open to roughly a hundred device firms with traditional 510(k)s under review between March and May of this year.