Tag: CoFi

FDA grants “Breakthrough Device Designation” to CorFlow Therapeutics to expedite clinical development and regulatory review of its CoFI™ (COF-fee) System

BAAR, Switzerland–(BUSINESS WIRE)–CorFlow Therapeutics AG (www.corflow-therapeutics.ch) today announced that the FDA has designated the company’s CoFI (CorFlow Controlled Flow Infusion) System as a “Breakthrough Device” with a broad indication-for-use statement: “The CoFI™ System is indicated for diagnostic assessment of the coronary microcirculation immediately following PCI […]