Koios Medical announces CE mark approval and European market launch for breast cancer detection AI software

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Koios Medical announces CE mark approval and European market launch for breast cancer detection AI software

Press releases may be edited for formatting or style | March 19, 2021 Artificial Intelligence Health IT Women's Health
NEW YORK, NY, USA, March 16, 2021 /EINPresswire.com/ -- Koios Medical, Inc., a fast-growing developer of artificial intelligence software for physicians announced it has received Conformité Européenne (CE) Mark approval for its flagship Koios DS Breast decision support software for interpreting breast ultrasound images. Available commercially in the US since 2018, physicians using the software consistently find cancer detection rates increase while simultaneously reducing all too common and costly false positive, benign biopsy rates, effectively elevating the accuracy of diagnosis and the quality of care provided to patients.

Initially cleared for use by the USFDA in late 2016 with an upgraded version also cleared in mid-2019, Koios DS AI software is deployed at a rapidly growing number of hospital systems, clinics and academic medical centers in the US, the Middle East and South America. CE Marking now makes this innovative software commercially available in another 38 countries across Europe and beyond. One out of every eight women is expected to contract breast cancer over the course of her lifetime making breast cancer the leading cancer diagnosis in women worldwide. The earliest possible detection is critical to increased survival rates. The use of AI software can dramatically expand access to quality care, improve accuracy, early diagnosis and survival.

Koios DS Breast Smart Ultrasound AI software was trained on over 500,000 ultrasound images of both malignant and benign breast lesions to improve physician diagnostic accuracy. The system generates a likelihood of malignancy finding aligned to both the American College of Radiology’s BI-RADS rating schema and the European five-point rating systems to both streamline workflow and ensure a proper treatment pathway.

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Despite the advances of mammography technology, ultrasound remains the standard of care modality for nearly half the women around the world that have dense breast tissue. Both cancer and dense breast tissue appear indistinguishable from one another on a mammogram making ultrasound the recommended and preferred imaging modality to accurately diagnose abnormalities found during routine screening. Using AI to analyze ultrasound images holds the promise of reducing breast cancer mortality worldwide with improved diagnostic accuracy while also eliminating avoidable benign biopsies.

“We could not be more pleased to introduce our innovative AI software for breast ultrasound exam interpretation to physicians in the UK, EU, Turkey and beyond.” Says Dr. Lev Barinov, VP of Clinical Excellence. “Use of Koios DS Breast can consistently elevate the performance of any trained physician interpreting breast ultrasound to the level of accuracy of a world class breast expert.”

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