Thursday, 28 October 2021

Claritas secures FDA 510(k) clearance for iRAD™ medical image enhancement software

KUALA LUMPUR, Oct 27 -- Claritas HealthTech Pte Ltd (Claritas), a healthcare technology company, announced 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, according to a statement.

“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,” said Director of R&D, Dr Laszlo Neumann. 

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. It enhances medical images to help radiologists in improved interpretation of MRI, CT and X-Ray images, thereby achieving correct diagnosis faster and alleviating bottlenecks.

The iRAD™ image enhancement technology forms the foundation of the company’s product suite including its AI based predictive diagnostic solutions.

More details at www.claritashealthtech.com.

-- BERNAMA


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