FDA Update On Heater-Cooler Devices Seeks New Designs To Reduce Infections
The US FDA has published updated information on heater-cooler devices used to warm or cool patients during surgery, which says the agency is working with industry to bring to market innovative devices that lower the risk of bacterial infection.
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The US FDA has updated guidance on computer-assisted detection devices that was first released in 2012. The document, which is intended to help developers win FDA approval of their products, was last updated in 2020.
The US FDA has labelled a recall of several hundred components of the LifeSPARC circulatory support system from LivaNova as class I, the agency’s most serious recall designation.
FDA Publishes Final Guidance On Clinical Decision Support Software, Clarifies What Software Should Be Regulated As Medical Devices
In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision support software from being regulated as medical devices under federal law. Software must meet all four criteria to be excluded.