The U.S. Food and Drug Administration (FDA) recently issued 510(k) clearance for Koios DS Breast 2.0, an innovative version of the AI-based diagnostic software by Koios Medical, a top provider of decision support software for ultrasound diagnostics.

Fremont, CA: Koios DS (Decision Support) Breast 2.0, the recently launched AI-based diagnostic tool, enables a machine-learning powered approach towards detecting and classifying types of breast cancer. The diagnostic software is now officially available for use at point of care.

The automated Koios DS Breast 2.0 can offer a proprietary configuration to BI-RADS (Breast imaging-reporting and data system) for any lesion detected and can also be connected to PACS (picture archiving and communication system) imaging technology. 

The firm has always been focused on enabling improved diagnostic accuracy to physicians and the recent launch is considered an important step towards achieving this.

The Koios DS Breast 2.0 combines the best available high-end AI-powered diagnostic technology until the date for ultrasound image analysis. In addition, this patented diagnostic tool also cuts down biopsies of benign tissues.

In spite of significant advances in modern imaging and genetics, the cases of late diagnosis are still on the rise. Early detection is a critical factor in determining the outcome of cancer treatment. Late diagnosis refers to more rigorous and prolonged treatments, medical expenses, and uncertain results.

 "We are seeing the promise of machine learning as a physician's assistant coming to fruition. This will undoubtedly improve quality, outcomes, and patient experiences—and ultimately save lives. Koios DS Breast 2.0 is proving that a system trained by hundreds of thousands of images linked to their ground truth can catch many more cancers earlier, while simultaneously reducing benign biopsies and all the anxiety, complications, and associated expense. Smart ultrasound is a second set of eyes that achieves what was previously unthinkable," says Koios Medical CEO Chad McClennan.

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Further, this diagnostic software is built with an ability to be used in conjunction with majority of PACS platforms. Also, it is directly available on GE Healthcare’s LOGIQ™ E10, the next-gen digital ultrasound system. The LOGIQ™ AND Koios DS Breast 2.0 together, can optimize diagnostic procedures by incorporating cloud connectivity, AI, and high-end algorithms to restructure the huge volumes of diagnostic data.  The results, thus obtained, could be incorporated directly into patient records.