26 Oct 2021

Claritas HealthTech Receives FDA 510(k) Clearance for iRAD™ Medical Image Enhancement Software for MRI, CT, and X-Ray

Claritas HealthTech

SINGAPORE, Oct. 26, 2021 (GLOBE NEWSWIRE) — Claritas HealthTech Pte. Ltd. (“Claritas”), a healthcare technology company specializing in AI-assisted diagnosis and image enhancement to improve the quality and efficiency of medical imaging, announces today it has received 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 there is 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 institutions 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.

About Claritas HealthTech Pte. Ltd.

Claritas conducts research and development in the fields of image enhancement, machine vision and artificial intelligence (“AI”) with a focus on medical image processing and AI assisted interpretation and diagnostics. Claritas aims to transform the diagnostics industry with powerful and effective software products created using image enhancement and AI technology enabling doctors and physicians to make accurate diagnosis and improve patient lives.

All Claritas products including iRAD™ are fully compliant with HIPPA and GDPR requirements.

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