• Blood flow, perfusion imaging device receives FDA clearance

    2 monthes ago - By Healio

    RFPi announced that a blood flow and perfusion imaging medical device for use during open surgery has received 510 clearance from the FDA.
    The device shows real-time perfusion and blood flow in critical tissues and vascular structures during surgeries without the use of dyes, injections, direct patient contact, radiation or procedure interruption, according to a press release from the company. It has been cleared for imaging in tissues up to 4 mm to 5 mm.
    “Repeat surgery rates in iCertainty's target indications run as high as 20% - a figure that masks a
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