RFPi Blood Flow And Perfusion Imaging Device Cleared

FDA has cleared an RFPi Inc. 510(k) for its iCertainty open surgery blood flow and perfusion imaging medical device, which is intended to show real-time blood flow and perfusion in vascular structures and critical tissues during surgeries. The company says iCertainty does not require injections, dyes, radiation, direct patient contact or interrupting a surgical procedure as other traditional methods — such as X-ray, ultrasound and MRI — do. It uses multi-spectral physiologic visualization, comprising low-energy lasers, high-speed imaging cameras and proprietary analysis techniques and flow-calculation algorithms to deliver real-time visualization and blood flow quantification.

iCertainty has been cleared by FDA for imaging blood flow and perfusion in tissue up to a depth of 4-5mm. The company expects that initial early applications will involve gastrointestinal and plastic surgeries as well as lower leg vascular procedures.