Kinepict Health announced today that it won FDA 510(k) clearance for its Kinepict Medical Imaging Tool (KMIT) imaging software with its proprietary digital variance angiography (DVA).
The Budapest, Hungary-based company’s DVA technology is designed with an algorithm to use advanced statistical methods in visualizing blood vessels by identifying contrast-induced changes in an X-ray angiography image series.
Clinical studies revealed that DVA provides superior image quality compared to digital subtraction angiography (DSA) and could potentially make X-ray angiography safer and more powerful, according to a news release.
Kinepict said its technology is clinically proven to improve image quality for both positive and negative contrast media. It also allows a 70% X-ray dose reduction compared to DSA imaging in the lower limb, plus a 50% contrast agent reduction compared to DSA in the carotid.
DVA also provides superior image quality compared to DSA when imaging blood vessels near metal implants and during prostate embolization, the company said.
Kinepict said the FDA clearance brings it a step closer to launching the technology in the U.S., as the company is planning to open talks with potential partners from the imaging industry or other health organizations in the angiography field.