iCertainty Contact-Free Perfusion Imaging System Cleared in U.S

RFPi, a company out of Greenville, North Carolina, won FDA clearance for its iCertainty blood flow and perfusion imaging system. The technology gives clinicians the ability to essentially watch as blood saturates or drains in tissues being worked on, something that typically has to be done using invasive means. The new technology avoids injection of dyes and the use of fluoroscopes that emit ionizing radiation, and may be an alternative to interoperative MRI scanning in some cases.

RFPi believes that many surgical procedures can be done faster, more easily, and with fewer complications, particularly where perfusion imaging is not currently performed because of cost or other limitations. “Repeat surgery rates in iCertainty’s target indications run as high as 20 percent — a figure that masks a tremendous amount of patient discomfort, uncertainty and inconvenience, as well as financial loss for hospitals and insurers,” in a published statement said Jeffery Basham, CEO of RFPi. “iCertainty offers an entirely new and advanced standard of imaging detail, speed, ease and flexibility that should benefit surgeons, hospitals and third-party payers — and, most importantly, the patients they all care for.”

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