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. Read the full article.

This milestone is an important step in advancing the company’s mission of empowering physicians to improve diagnostic accuracy. Now cleared for use at the point of care (or connected to an image viewer for studies stored on PACS), Koios Medical’s advancements represent a huge leap forward in using artificial intelligence in healthcare by bringing the power of deep learning to physicians’ fingertips. Koios DS Breast 2.0 represents the most advanced AI-based diagnostic technology for ultrasound image analysis to date. This patented software uses an ensemble of algorithms to aid the early detection of disease while also reducing biopsies of benign tissue.