An FDA staffer trying to create an informal, "interactive review" process for devices warned companies last week that even under the new system they should not expect extensive discussion without temporarily halting review of an application
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An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.
A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.
