FDA Clears Koios DS Breast 2.0 to Assist Physicians with AI-Based Software

Koios Medical, Inc has received 510(k) clearance from the U.S. Food and Drug Administration for Koios DS (Decision Support) Breast 2.0, 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.