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Medical Devices / Submissions and Approvals

FDA Clears RFPi’s Blood Flow Imaging Device

Jan. 22, 2019

The FDA granted 510(k) clearance for RFPi’s iCertainty, a non-invasive blood flow and perfusion imaging device for use in surgical procedures.

The device shows a patient’s blood flow without interrupting surgery or requiring dyes, radiation, injections or direct patient contact.

The product is cleared for imaging blood flow and perfusion in tissue up to 4-5mm in depth. It’s initial uses include lower-leg vascular procedures and gastrointestinal and plastic surgeries.

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