RadNet Subsidiary Captures Mammography AI FDA Clearance

AI-fueled mammography triage software from DeepHealth wins 510(k).

Artificial intelligence (AI) developer DeepHealth, a subsidiary of RadNet, announced Monday it has secured 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its mammography triage solution, Saige-Q.

This AI-driven screening worklist prioritization tool is DeepHealth’s first cleared product, and it automatically identifies screening exams that have suspicious findings that require additional evaluation, company officials said. By identifying these cases, the software helps radiologists streamline their workflow to be more efficient and effective.

“Saige-Q is built using our core artificial intelligence algorithms, described in a recent article in Nature Medicine,” said Bill Lotter, Ph.D., chief technology officer, and DeepHealth co-founder. “As the FDA-cleared mammography triage product that supports 3D mammography in addition to 2D mammography, Saige-Q demonstrates high performance that is maintained across different breast densities and lesion types.”

It is a tool that is designed to increase radiologist confidence in their ability to pinpoint suspicious findings, bolstering their ability to provide high-quality care.

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