Kinepict Health Ltd. has received U.S. 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 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. The proprietary 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 dramatically 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 vs. increased contrast media,” according to a press release.
The press release states that 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 start of launch of the technology onto the U.S. market. The company is open for talks with potential partners from the imaging industry or other health service organizations active in the angiography field.