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breakthrough devices program

Reflow Medical’s retrievable stent technology, Temporary Spur Stent System, has been designated for the Breakthrough Devices Program by the U.S. Food and Drug Administration (FDA). Read more

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Heart device company BioVentrix has received Breakthrough Device Designation from the Food and Drug Administration (FDA) for its Revivent TC Transcatheter Ventricular Enhancement System for heart failure. Read more

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CSA Medical has announced its RejuvenAir System has been designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA). Read more

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The Food and Drug Administration has announced it is finalising guidance on its existing Breakthrough Devices Program as well as announcing plans for a Safer Technologies Program (STeP). Read more

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