FDA clears RadNet subsidiary DeepHealth's AI mammography triage software Saige-Q

RadNet announced Monday that its DeepHealth subsidiary received FDA clearance for Saige-Q, the company's first artificial intelligence (AI)-based mammography triage software. "We have developed an advanced algorithm to support radiologists with the significant challenge of finding breast cancer as early as possible," commented DeepHealth CEO Gregory Sorensen, adding the tool helps "optimise how and when they read cases marked by Saige-Q as suspicious or those not marked as suspicious."

A recent paper in Nature Medicine comparing the AI to five expert radiologists who read the same screening mammograms suggested DeepHealth's technology could help detect cancer one to two years earlier than standard interpretation in many cases, according to the company. Chief technology officer Bill Lotter noted that the triage product supports 3D and 2D mammography, and also "demonstrates high performance that is maintained across different breast densities and lesion types."

More advanced algorithm to be submitted to FDA

The company describes Saige-Q as a screening worklist prioritisation tool that automatically singles out suspicious exams that may need more immediate attention, enabling "radiologists to optimise their workflow for efficiency and effectiveness."

Meanwhile, RadNet CEO Howard Berger remarked that "with the almost 2 million mammography exams we perform annually in our markets, we will now begin to deploy this tool." He added that "the efficiency gains and accuracy should be further enhanced by a more advanced diagnostic algorithm we plan to submit to the FDA for its review by year end."

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