iCAD Announces AERB Approval of Xoft System in India

A global medical technology leader providing innovative cancer detection and therapy solutions, announced today that its Xoft® Axxent® Electronic Brachytherapy (eBx®) System® has received an Atomic Energy Regulatory Board (AERB) Type Approval for use in India. The approval affirms that the system conforms to established safety standards and makes the full suite of the Company’s electronic brachytherapy products available to clinicians and patients across the country. The Omega Hospitals – Hyderabad, part of the Hyderabad Institute of Oncology, is the first site to adopt the Xoft System in India. Omega Hospitals is a world-class, integrated healthcare delivery system providing more than 89,500 patient care visits annually.
“AERB approval of the Xoft System represents an important milestone in our continued efforts to provide healthcare facilities worldwide with leading-edge technology offering clinically-proven treatment options for a range of cancers,” said Ken Ferry, CEO of iCAD. “We are pleased to join with the Omega Hospitals to provide unprecedented access to this advanced therapy to patients in India, where cancer cases are significantly increasing. We look forward to partnering with additional providers to deliver electronic brachytherapy on a broader scale throughout the country.”
Omega Hospitals – Hyderabad will be utilizing the Xoft System for the treatment of early-stage breast cancer and gynecological cancers. 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. The system utilizes a proprietary, miniaturized x-ray source to deliver precise radiation treatment directly to a cancerous area while sparing surrounding healthy tissue. The system requires only minimal shielding and therefore does not require construction investment.
“At Omega Hospitals, we strive to provide patients with state-of-the-art treatment options and unparalleled medical expertise, resulting in outstanding patient care,” said Dr. Ch. Mohana Vamsy, Chief Surgical Oncologist at Omega Hospitals. “The Xoft System offers a uniquely valuable solution to eradicate an array of cancers, equipping us with cutting-edge technology that strongly aligns with our mission to deliver positive patient outcomes. We are pleased to partner with iCAD to offer electronic brachytherapy with the Xoft System to patients in India.”


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