FDA OKs Claritas’ Medical Image Enhancement Software

Claritas HealthTech Pte. Ltd., a company specializing in AI-assisted diagnosis and image enhancement to improve medical imaging quality and efficiency, earned 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market iRAD. Claritas iRAD is an image processing software that enhances MRI, CT, and X-Ray images through noise reduction and improvement in contrast and entropy.
 
Claritas has developed iRAD, an advanced proprietary image enhancement product that produces a significantly enhanced image while ensuring no alteration or degradation to the image. iRAD integrates easily into radiologists’ existing PACS becoming part of the clinicians’ workflow, where enhanced images can be compared with the original image. The image enhancement can be done locally on site (if required by the institution) or on the cloud, providing ease of access. The product provides physicians with adjustable controls to calibrate the degree of enhancement of each parameter.
 
iRAD addresses key challenges faced by the medical imaging industry, namely, the quality and clarity of radiology images. iRAD enhances medical images to help radiologists in improved interpretation of MRI, CT and X-Ray images, thereby achieving correct diagnosis faster and alleviating bottlenecks. Another crucial benefit that iRAD provides is the impact on data quality improvement for medical AI tools. iRAD enhanced images provide a vastly enhanced and superior data-source on which to train and develop AI predictive diagnostic products which result in significantly higher degrees of accuracy.
 
While iRAD is in pilot clinical use in multiple university and hospital centres, Claritas is in collaboration with medical intuitions for the development of AI predictive solutions for detection of chest and bladder conditions, leveraging the iRAD platform to provide a high-quality data-source for training of the AI predictive software.
 
Dr. Laszlo Neumann, director of R&D, said “We are pleased to receive the FDA 510(k) clearance for iRAD, and now look forward to entering the US market through partnerships with leading medical and academic institutions. Another very crucial factor for Claritas getting this clearance is the fact that our image enhancement software, iRAD, is the foundation of our future products, and it is what will set our coming AI diagnostic product suite apart.”
 
A key challenge and factor in determining the level of predictive accuracy of AI predictive diagnostic products is the quality of the data that is used to train and develop the neural networks. Claritas is in advanced-stage development of AI tools that have exceptionally high degree of predictive accuracy as they are trained on iRAD-enhanced images.
The iRAD image enhancement technology forms the foundation of the company’s product suite including its AI based predictive diagnostic solutions.