FDA Green Lights Blood Flow Imaging Device, iCertainty

The US Food and Drug Administration (FDA) has approved RFPi Inc’s blood flow and perfusion imaging medical device, iCertainty.

Setting it apart from other traditional modalities like X-rays, ultrasounds, and magnetic resonance imaging (MRIs), the device stands as the first commercially available device to not require injections, dyes, radiation, direct patient contact, or interruption of a surgical procedure.

With iCertainty, surgeons, hospitals, patients, and third-party payers have the potential to objectively measure and help to improve clinical outcomes as well as reduce procedural complications and repeat surgeries since the device allows surgeons to immediately visualize patient blood flow and perfusion during procedures.

“iCertainty has the potential to permanently change non-invasive medical imaging,” Jeffery Basham, CEO of RFPi, said in a recent statement. “It’s exciting to bring to market new technology that delivers in terms of safety and patient and surgeon benefits.”

Basham added that iCertainty’s target indications see repeat surgery rates as high as 20%—a number that does not show the severe degree of patient discomfort, uncertainty, inconvenience, and financial loss by hospitals and insurers.

The FDA has cleared the device for imaging blood flow and perfusion in tissue up to a depth of 4-5mm. Basham anticipates gastrointestinal, plastic surgeries, and lower-leg vascular procedures will be involved in the early applications.

With its multi-spectral physiologic visualization or MSPV technology, iCertainty also helps the field with even broader functionalities, says Basham. He noted that it delivers real-time visualization and quantification of blood flow and perfusion by using low-energy lasers, high-speed imaging cameras, proprietary analysis techniques, and flow-calculation algorithms.

Looking forward, investigators are assessing whether MSPV can monitor a patient’s basic cardiovascular parameters without touching the point and then transmitting that information to other healthcare providers. In trauma-care or battlefield situations, these implications may be especially substantial. Investigators are also developing a mobile device that could potentially be useful in outpatient settings like wound care and diabetic clinics.

“Multi-spectral physiologic visualization offers multiple applications to achieve different medical goals,” Basham said. “The possibilities are staggering.”