Biosensors International Wins FDA Approval For Drug-Eluting Coronary Stent
The US agency’s Center for Devices and Radiological Health has granted a PMA to Biosensors International USA for its BioFreedom drug-eluting coronary stent System to treat coronary artery disease.
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Medtech Insight’s Cardiovascular Catch-Up highlights recent news on cardiovascular tech innovations in the last two months. Part II of this month’s update includes innovative research and development news from smaller companies and research labs that you may have missed.
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.