Research & Development
Koios Medical awarded US FDA second marketing clearance for Koios DS Breast 2.0 to assist physicians with AI-Based software
10 July 2019 -

Ultrasound diagnosis company Koios Medical revealed on Tuesday the receipt of the second 510(k) clearance for its Koios DS (Decision Support) Breast 2.0 from the US Food and Drug Administration (FDA) to assist physicians analyzing breast ultrasound images with AI-Based software.

The company added that the Koios DS (Decision Support) Breast 2.0 is a new version of its machine learning based platform that assists physicians in the classification and diagnosis of breast cancer.The software offers a proprietary alignment to BI-RADS for any lesion analyzed and is available connected to PACS and/or directly on GE Healthcare's LOGIQ E10 ultrasound system.

In a recent reader study, the 15 physicians utilising the company's Koios DS 2.0 AI software experienced a statistically significant improvement in accuracy as measured by area under the ROC (receiver operating characteristic) curve (AUC), while simultaneously reducing both inter and intra-operator variability.

According to the company, the Koios DS Breast 2.0 can be used in conjunction with most major PACS platforms and is directly available on the LOGIQTM E10, GE Healthcare's next generation digital ultrasound system that integrates artificial intelligence, cloud connectivity and advanced algorithms to acquire and reconstruct data.



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