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FDA draft guidance addresses pulse oximeter accuracy, AI devices

The US Food and Drug Administration (FDA) has issued new draft guidance January 6 providing recommendations improving the use of pulse oximeters and supporting the safety of AI-enabled medical devices, among other topics. Released January…

AAMI updates sterilization materials compatibility guidance

The Association for the Advancement of Medical Instrumentation (AAMI) has released the updated AAMI TIR17:2024; Compatibility of Materials Subject to Sterilization, its first revision since 2017. This guidance provides essential information for medical device manufacturers,…

Study: Esophagectomy outcomes worse at private equity hospitals

A study published in JAMA Surgery revealed that hospitals owned by private equity firms had significantly worse outcomes for esophagectomy patients compared to non-acquired hospitals. As detailed in a January 2 report on the findings…

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