Kinepict medical imaging technology receives US FDA clearance
A new data analysis software for angiography is going to be launched in the US. Potential partners are being sought.The software increases image quality and allows a reduction of X-ray doses and contrast agents.
Kinepict Health, Budapest, Hungary, announced that it has received US FDA 510(k) clearance for its Kinepict medical imaging tool (KMIT) software, which uses the company’s proprietary digital variance angiography (DVA).
Kinepict’s DVA technology causes a change in the calculation of X-ray angiography images, a field in which the fundamental principles of data analysis were unchanged in the past four decades. The DVA algorithm uses advanced statistical methods to visualizes blood vessels by identifying contrast-induced changes in the X-ray angiography image series. First clinical validations show that DVA provides superior image quality compared to the state-of-the-art digital subtraction angiography (DSA). The improved image quality provided by DVA has the potential to make X-ray angiography safer and more powerful. Thus, the KMIT software can overcome the typical trade-off between increased X-Ray dose versus increased contrast media. The following indications have already been clinically validated, and several other clinical validations are underway:
(1) Using DVA instead of DSA greatly improves image quality (2.5 to 10 times better contrast-to-noise ratio) for both positive (iodinated) and negative (CO2) contrast media.
(2) DVA allows a 70% X-ray dose reduction (down to 30%) compared to DSA imaging the lower limb.
(3) DVA allows a 50% contrast agent reduction compared to DSA in imaging the carotid.
(4) DVA provides superior image quality compared to DSA when imaging blood vessels near metal implants.
(5) DVA provides superior image quality compared to DSA during prostate embolization.
The recent FDA clearance paves the way for a timely launch of the technology onto the US market. The Company is open for talks with potential partners from the imaging industry or other health service organizations active in the angiography field.