Blood flow imaging solution gains FDA clearance

RFPi, a Greenville, North Carolina-based medical imaging company, announced that its iCertainty blood flow and perfusion imaging solution has received FDA clearance.

iCertainty allows surgeons to visualize patient blood flow and perfusion without interrupting the procedure. According to RFPi, it is the first solution that provides this perspective without requiring injections, dyes, radiation or another type of direct patient contact.

“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,” Jeffery Basham, RFPi CEO, said in a prepared statement. “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.”

The company is currently securing Series B funding.