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# RFPi Blood Flow And Perfusion Imaging Device Cleared
- URL: https://www.fdaweb.com/rfpi-blood-flow-and-perfusion-imaging-device-cleared/
- Published: 2019-01-11T12:00:00.000Z
- Updated: 2026-09-15T00:53:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143138

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.