www.fdanews.com/articles/206253-claritas-healthtech-gets-510k-clearance-for-its-claritas-ipet-software
Claritas HealthTech Gets 510(k) Clearance for its Claritas iPET Software
January 21, 2022
Claritas HealthTech has received the FDA’s 510(k) clearance to market its Claritas iPET image processing software.
The Singapore-based company specializes in deep-learning and advanced image enhancement to improve AI-assisted diagnosis. The software includes an algorithm that improves the quality of positron emission tomography (PET) scans by sharpening organ boundaries.
The PET scans can be further improved with the software to provide additional details by using an overlay of a magnetic resonance image or a computed tomography image of the same region.
The iPET software can reduce scan times by up to 80 percent, the company said.