News | Ultrasound Women's Health | July 11, 2019

Machine learning-based software offers 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

FDA Clears Koios DS Breast 2.0 AI-based Software

July 11, 2019 — Koios Medical announced 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. It aligns a machine learning-generated probability of malignancy with the appropriate BI-RADS (Breast Imaging-Reporting and Data System) category.

The software is cleared for use at the point of care, or connected to an image viewer for studies stored on picture archiving and communication systems (PACS). According to the company, Koios DS Breast 2.0 represents the most advanced artificial intelligence (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.

In a recent reader study involving 15 physicians with relevant experience up to 39 years, each randomly analyzed 900 cases twice, separated by a one-month "washout period."  Physicians utilizing the Koios DS 2.0 AI software experienced a statistically significant improvement in accuracy as measured by area under the receiver operating characteristic (ROC) curve, while simultaneously reducing both inter- and intra-operator variability.

Koios DS Breast 2.0 can be used in conjunction with most major PACS platforms and is directly available on the next-generation Logiq E10 digital ultrasound system from GE Healthcare. The Logiq E10 integrates AI, cloud connectivity, and advanced algorithms to acquire and reconstruct data. Machine-generated results can be exported directly into a patient's record. 

Koios Medical continues to experiment with thyroid ultrasound image data and expects to add to its offering later this year.

For more information: www.koiosmedical.com

Related Content

Ways to Increase Productivity and Efficiency in Breast Imaging

Development of Artificial Intelligence in Women’s Health Emphasizes Value

Technology to Watch in Breast Imaging

Related Content

News | Ultrasound Imaging

June 28, 2022 — Mindray, a global leader and developer of healthcare technologies and solutions for ultrasound, patient ...

Time June 28, 2022
arrow
News | Mammography

June 23, 2022 — Black and Asian women are more likely than white women to experience significant delays in getting ...

Time June 23, 2022
arrow
News | Radiology Business

June 22, 2022 — Blackford, a medical imaging AI platform leader that helps healthcare professionals add clinical value ...

Time June 22, 2022
arrow
News | MRI Breast

June 22, 2022 — According to ARRS’ American Journal of Roentgenology (AJR), contrast-enhanced mammography (CEM) may be a ...

Time June 22, 2022
arrow
News | Radiation Therapy

June 17, 2022 — Accuray Incorporated and Limbus AI Inc. announced they are partnering to augment Accuray adaptive ...

Time June 17, 2022
arrow
News | Artificial Intelligence

June 14, 2022 — According to ARRS’ American Journal of Roentgenology (AJR), incorporating AI support into clinical ...

Time June 14, 2022
arrow
News | PACS

June 10, 2022 — Candelis, Inc., a leading provider of innovative and cost-effective data management and PACS solutions ...

Time June 10, 2022
arrow
News | Breast Imaging

June 10, 2022 — According to a new study, use of breast imaging services — including mammography screening — may remain ...

Time June 10, 2022
arrow
News | Breast Imaging

June 10, 2022 — Targeted text reminders and other interventions erased disparity in the rate of breast cancer screening ...

Time June 10, 2022
arrow
News | Artificial Intelligence

June 9, 2022 — Infinitt North America and Brainreader A/S announced today a wide ranging and unique partnership to ...

Time June 09, 2022
arrow
Subscribe Now