US FDA Okays Clinical Trial For Thermedical’s Heart Ablation System
Company encouraged by early data
The US FDA has given the greenlight to a clinical trial that has the potential to transform how patients with ventricular tachycardia are treated.
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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.
As part of a policy revamp, FDA encourages COVID-19 test developers to pursue traditional premarket review pathways rather than emergency use authorizations.
As part of a policy revamp, the US FDA is encouraging COVID-19 test developers to pursue traditional premarket review pathways rather than emergency use authorizations.