Starting next October, every 510(k) sent to FDA will have to be compiled with CDRH’s eSTAR electronic template and submitted via its new online portal. Here’s a look at this big shift from the device center’s analog past and some expert tips on making the transition.
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Healthcare systems and other stakeholders are forming innovative data-sharing collaborations to transform care. We speak with WashU’s Philip Payne, a pioneer in integrating data science into healthcare systems, and also look at BSX/Truveta's data sharing partnership. Plus three very informed takes on the future of medical robotics, a look at new players in electrophysiology, GT Medical’s implantable radiotherapy for brain tumors, and profiles of AI Medical Technology and FeelBetter.
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Some committee leadership posts will change hands following the midterm elections. Excerpted from Pathways’ Picks November 9: US Midterms, EU Gatherings, and More to Watch.