A New York City based large volume private practice radiology group conducted a quality assurance review that included an 18 month software evaluation in the breast center comprised of nine (9) specialist radiologists using an FDA cleared artificial intelligence software by Koios Medical, Inc as a second opinion for analyzing and assessing lesions found during breast ultrasound examinations. Over the evaluation period, radiologists analyzed over 6,000 diagnostic breast ultrasound exams. Radiologists used Koios DS Breast decision support software (Koios Medical, Inc.) to assist in lesion classification and risk assessment. As part of the normal diagnostic workflow, radiologists would activate Koios DS and review the software findings with clinical details to formulate the best management. Analysis was then performed comparing the physicians' diagnostic performance to the 18-month period prior to the introduction of the AI enabled software.

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.