Baxter Wins 510(k) Clearance For New Infusion Pump With Safety Software
The US FDA has granted Baxter International 510(k) clearance for its new Novum IQ syringe infusion pump with safety hardware. The approval opens a new market opportunity for the company.
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The US agency said the device maker initiated the recall in December because the pumps might not alarm for repeated occlusion events.
The urgent safety communication says the company has been notified about 51 serious injuries and three deaths related to issues with the pumps’ upstream occlusion alarms.
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.