Claritas HealthTech Receives FDA 510 (k) Clearance for


SINGAPORE, October 26, 2021 (GLOBE NEWSWIRE) – Claritas HealthTech Pte. Ltd. (“Claritas”), a healthcare technology company specializing in AI-assisted diagnostics and image enhancement to improve the quality and efficiency of medical imaging, today announces that it has received 510 (k) clearance of the United States Food and Drug Administration (FDA) to market iRAD â„¢. Claritas iRAD â„¢ is image processing software that enhances MRI, CT and X-ray images by reducing noise and improving contrast and entropy.

Claritas has developed iRAD â„¢, a proprietary and advanced image enhancement product that produces a dramatically enhanced image while ensuring that there is no alteration or degradation of the image. iRAD â„¢ easily integrates into radiologists’ existing PACS and is part of the clinician workflow, where the enhanced images can be compared to the original image. Image enhancement can be done locally on premise (if required by the institution) or in the cloud, providing ease of access. The product provides physicians with adjustable controls to calibrate the degree of improvement in each parameter.

iRAD â„¢ addresses the main challenges faced by the medical imaging industry, namely the quality and clarity of radiological images. iRAD â„¢ enhances medical images to help radiologists better interpret MRI, CT and X-ray images, helping to get a correct diagnosis faster and reducing bottlenecks. Another crucial benefit of iRAD â„¢ is the impact on improving data quality for medical AI tools. The enhanced iRAD â„¢ images provide a vastly improved and superior data source upon which to train and develop AI predictive diagnostics products that result in significantly higher degrees of accuracy.

While iRAD â„¢ is in pilot clinical use in several university and hospital centers, Claritas is collaborating with Medical Insights for the development of predictive AI solutions for the detection of thoracic and bladder conditions, taking advantage of the iRAD â„¢ platform to deliver high quality data. source for training AI predictive software.

Dr Laszlo Neumann, Director of R&D, said:

We are delighted to have received 510 (k) clearance from the FDA for iRAD and are now eager to enter the US market through partnerships with leading medical and academic institutions. Another very crucial factor for Claritas to obtain this clearance is the fact that our image enhancement software, iRAD, is the foundation of our future products, and this is what will differentiate our next suite of AI diagnostic products.. “

A challenge and a key factor in determining the level of predictive accuracy of AI predictive diagnostics products is the quality of the data used to train and develop neural networks. Claritas is in the process of developing AI tools at an advanced stage that have an exceptionally high degree of predictive accuracy as they are trained on images enhanced by iRAD.

IRAD â„¢ image enhancement technology forms the basis of the company’s product line, including its AI-based predictive diagnostic solutions.

About Claritas HealthTech Pte. Ltd.

Claritas conducts research and development activities in the areas of image enhancement, machine vision and artificial intelligence (“AI”) with a focus on medical image processing and AI-assisted interpretation and diagnosis. Claritas aims to transform the diagnostics industry with powerful and efficient software products created using image enhancement and AI technology that enable physicians and physicians to accurately diagnose and d ” improve the lives of patients.

All Claritas products, including iRAD â„¢, are fully compliant with HIPPA and GDPR requirements.

For more information, please visit www.claritashealthtech.com

For media inquiries, please contact:

Devika Dutt, COO
(+65) 9795 1921
[email protected]

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