Kinepict Health has received FDA 510(k) clearance for its Kinepict Medical Imaging Tool (KMIT) software, which uses the Digital Variance Angiography (DVA).
Kinepict’s DVA technology aims to revolutionise the calculation of X-ray angiography images. The DVA algorithm uses advanced statistical methods to visualise 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 Digital Subtraction Angiography (DSA).
The improved image quality provided by DVA has the potential to make X-ray angiography safer and more powerful. The KMIT software aims to overcome the typical trade-off between increased X-ray dose vs. increased contrast media. The following indications have already been clinically validated, and several other clinical validations are underway:
- Using DVA can improve image quality (2.5 to 10 times better contrast-to-noise ratio) for both positive (iodinated) and negative (CO2) contrast media.
- DVA allows a 70% X-ray dose reduction (down to 30%) compared to DSA imaging the lower limb.
- DVA allows a 50% contrast agent reduction compared to DSA in imaging the carotid.
- DVA can provide superior image quality compared to DSA when imaging blood vessels near metal implants.
- DVA can provide superior image quality compared to DSA during prostate embolization.
The recent FDA clearance paves the way for a US market launch.
