FDA Wants Resubmission On PAVmed Carpal Tunnel Syndrome 510(k)
Device manufacturer PAVmed is planning to resubmit a 510(k) for its CarpX product to treat carpal tunnel syndrome after US FDA said it couldn’t reach a consensus on approval.
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Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by MedDeviceTracker. This edition covers trial announcements from Jan. 7 through Jan. 27, including announcements from Medtronic, QT Vascular, Boston Scientific, and Shockwave.
What lessons can be learned from the conviction of Theranos founder Elizabeth Holmes, found guilty on four counts of investor fraud in a US court on 4 January?
Elizabeth Holmes has been convicted on four counts of investor fraud. Two attorneys who followed the case spoke to Medtech Insight about what happened – and what it could mean for industry as a whole.