ArcBlate

ArcBlate 100M is a MR-guided High Intensity Focused Ultrasound（MRgHIFU) designed to be use with magnetic resonance imaging (MRI) system. Using the MRgHIFU to perform a non-invasive procedure through a top-mounted transducer for soft tissue ablation in the Uterus (Uterine Fibroids and Adenomyosis).

Our device use ultrasound beams penetrate soft tissue and focus on the targeted tissue. The focused ultrasound energy release heat that could be absorbed by the targeted tissues causing transient high temperature (65-85℃) at the focal region. This transient heat generates results in protein denaturation, irreversible cell damage and coagulative necrosis without disrupting skin, adjacent normal tissue, and non-therapy regions.

During the treatment ArcBlate 100M operates with the MRI system to provide a high-resolution anatomical image for treatment planning as well as real-time thermal monitoring throughout the therapy. Thus ensures the patient’s safety.

Strengths of ArcBlate 100M

-Real-time thermal image
-Top-mounted transducer
-Non-invasive soft tissue ablation

Regulatory Approvals

ArcBlate 100M have obtained the certificate from FDA in Taiwan for class 3 device.
Is in the process of obtaining the CE MDR.

Treatment Center

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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 the updated ABUS system is also 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.

  • Natural Compression of the breast in prone position
  • Efficient Radial Review of The Entire Breast Volume
  • Computerized Acquisition of the Whole Breast in Minutes
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