MRI Guided High Intensity Focused Ultrasound Tumor Ablation System (MRgHIFU) –

EpiSonica’s MRgHIFU, ArcBlate 100M, offers non-invasive thermal ablation treatments for uterine fibroids, adenomyosis and pain palliation of bone metastases. This product has received TFDA approval as Class III medical device and is under CE MDR reviewing. EpiSonica’s first MRgHIFU system has been installed at Dalin Tzu Chi Hospital (Taiwan) to provide a new treatment option for uterine fibroids and adenomyosis.
 

Automated Whole Breast Ultrasound Tomography System (ABUS) –

​EpiSonica’s ABUS, iABUS, is designed to be a supplemental detection to mammogram aiming at women with dense breasts for breast cancer screening. The TFDA-cleared iABUS system has received CB Test Certificate and Report in compliance with international standards for IEC 60601-1 (safety and effectiveness of medical electrical equipment) and IEC 60601-1-2 (electromagnetic disturbances of medical electrical equipment). Currently, we are seeking strategic partner for licensing out.