www.fdanews.com/articles/189932-fda-clears-rfpis-blood-flow-imaging-device
FDA Clears RFPi’s Blood Flow Imaging Device
January 18, 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.