Medical software company gains FDA clearance for digital angiography platform
Budapest, Hungary-based Kinepict Health has received U.S. Food and Drug Administration clearance for its new digital angiography imaging software, the company announced Tuesday, March 10.
Kinepict, a medical software company founded in 2015, gained 510(k) clearance for its Digital Variance Angiography platform. It uses algorithmic methods to visualize blood vessels by pinpointing contrast-induced changes in x-ray angiography images.
Preliminary research has shown that DVA-produced images are higher-quality and may ultimately make the technology more powerful and safer for patients, the company said.
In fact, according to those clinical studies, DVA can reduce x-ray radiation dose by 30%, compared to state-of-the-art digital subtraction angiography. The former also requires 50% less contrast agent compared to DSA when imaging the carotid.
“Kinepict’s DVA technology revolutionizes the calculation of x-ray angiography images, innovating a field in which the fundamental principles of data analysis were unchanged in the past four decades,” according to the announcement.
Kinepict said this clearance paves the way for the technology to enter the U.S. market, and its talking with industry players for potential partnerships to make that happen.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.