Organ Preservation: FDA Weighs Animal Study Questions For Machine Perfusion Devices
US FDA has drafted a guidance exploring when developers of transplant organ preservation devices should rely on ex vivo versus in vivo animal studies, among other questions.
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New final guidance from the US FDA discusses how to model clinical trials for new organ-preservation devices, including those using animals.
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On the latest Medtech Insight podcast, David Filmore and Ferdous Al-Faruque discuss the unexpected news that Scott Gottlieb is leaving US FDA next month. What has been his legacy for medtech, and who will replace him?