Ultrasound diagnosis company Koios Medical revealed on Tuesday the receipt of the second 510(k) clearance for its Koios DS (Decision Support) Breast 2.0 from the US Food and Drug Administration (FDA) to assist physicians analyzing breast ultrasound images with AI-Based software.
The company added that the Koios DS (Decision Support) Breast 2.0 is a new version of its machine learning based platform that assists physicians in the classification and diagnosis of breast cancer.The software offers a 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.
In a recent reader study, the 15 physicians utilising the company's Koios DS 2.0 AI software experienced a statistically significant improvement in accuracy as measured by area under the ROC (receiver operating characteristic) curve (AUC), while simultaneously reducing both inter and intra-operator variability.
According to the company, the Koios DS Breast 2.0 can be used in conjunction with most major PACS platforms and is directly available on the LOGIQTM E10, GE Healthcare's next generation digital ultrasound system that integrates artificial intelligence, cloud connectivity and advanced algorithms to acquire and reconstruct data.
CARsgen Therapeutics' satri-cel NDA accepted by Chinese regulator
Sanofi receives FDA orphan drug designation for riliprubart in transplant rejection
Hoth Therapeutics reports positive interim results for HT-001 topical therapy
Breckenridge Pharmaceutical's generic for Ablysinol granted final FDA approval
Hemab Therapeutics presents bleeding disorder clinical and preclinical data at ISTH 2025 Congress
Cumberland Pharmaceuticals reports ifetroban Phase 2 DMD heart disease trial results
Sarclisa recommended for EU approval in newly diagnosed transplant-eligible multiple myeloma