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

July 09, 2019 / PR Newswire

Koios Medical, the leader in ultrasound diagnosis decision support software, announces its second 510(k) clearance from the U.S. Food and Drug Administration (FDA). Koios DS (Decision Support) Breast 2.0 is intended for use to assist physicians analyzing breast ultrasound images and aligns a machine learning generated probability of malignancy with the appropriate BI-RADS category.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 o...

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