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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.
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.
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.