Noninvasive blood flow imaging device receives FDA clearance

The FDA recently gave 501(k) clearance to noninvasive imaging solution iCertainty which shows blood flow without the need of injection, dyes or radiation. The device, developed by RFPi, It is the first device that does not require interruption during a surgical procedure, according to the company

iCertainty shows real-time blood flow and perfusion in vascular structures and critical tissues during surgical procedures. Notably, it eliminates the need for x-ray, ultrasound and MRI interruption during surgery.

“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,” said Jeffery Basham, CEO of RFPi, in a press release. “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.”