iCAD announced that researchers from Hospital Universitario Miguel Servet in Zaragoza, Spain will present new results from three clinical studies supporting the efficacy of the Xoft Axxent Electronic Brachytherapy System for the treatment of early-stage breast cancer and gynecological cancers during the European Society for Radiotherapy & Oncology meeting at the Barcelona International Convention Centre in Barcelona, Spain. The Xoft System is a proprietary eBx platform designed to deliver isotope-free radiation therapy. At ESTRO 37, clinicians from Hospital Universitario Miguel Servet will present new preliminary findings from three studies that further demonstrate the efficacy of the Xoft System in the treatment of early-stage breast cancer and gynecological cancers. Since their adoption of the technology in 2015, clinicians at Hospital Universitario Miguel Servet have treated more than 350 early-stage breast cancer and gynecological cancer patients with the Xoft System. Preliminary results in 94 patients treated from September 2015 to September 2017 show targeted approach reduces toxicity to organs at risk. The Xoft System is FDA cleared, CE marked, and licensed in a growing number of countries for the treatment of cancer anywhere in the body, including early-stage breast cancer, gynecological cancers and non-melanoma skin cancer. It uses a proprietary, miniaturized x-ray source to deliver targeted radiation directly to the cancerous site, sparing healthy tissues and surrounding organs. The Xoft System is highly mobile and requires minimal shielding, allowing it to be used in a variety of clinical settings and eliminating the need for room redesign or construction investment.
iCAD received CE Mark approval for PowerLook Tomo Detection 2.0, the company's second deep-learning based computer aided detection solution. This innovative breast cancer detection solution is compatible with Hologic, GE and Siemens systems. Using a unique algorithm that is trained to detect malignancies and determine the probability of cases having malignant findings, PowerLook Tomo Detection 2.0 provides radiologists with a "certainty of finding" score for each detected lesion.
iCAD announced that the company's Xoft Axxent balloon applicators have received approval from the China Food & Drug Administration, or CFDA, for the treatment of early-stage breast cancer. The Xoft Axxent balloon applicators are a key component of the Xoft Axxent Electronic Brachytherapy, or eBx System, which is used to perform intraoperative radiation therapy, or IORT, in early-stage breast cancer patients who meet specific selection criteria. With this CFDA approval, the complete suite of Xoft System products is now available to clinicians and patients in China.