U.S. Launch Set as Dilon Technologies Gains FDA Approval for MarginProbe® 2
Published: 16 Dec 2025
Author: Precedence Research
Dilon Technologies, known as a pioneer in breast cancer surgical technologies, has declared approval by the U.S. Food and Drug Administration (FDA) and introduction of its third-generation MarginProbe 2 system throughout the U.S. The new device is a significant enhancement to the usual procedure of breast-conserving surgery. It allows a surgeon to ascertain the presence of cancerous tissue within the margins of that tissue whilst still in the operating room.
MarginProbe 2 can contribute to substantial reductions in repeat operations and improvements in clinical outcomes and patient experience by delivering timely, efficient feedback. The new system provides improved performance and functionality based on the firm’s clinical foundation of the original MarginProbe. That is the sole real-time margin assessment device having a robust body of published clinical evidence. It has been found that the initial MarginProbe decreased the re-excision rate by an average of over 54%, which is one of the most common issues in lumpectomy operations.
MarginProbe 2 will fit well within the current operating room setting, regardless of hospital size or surgical volume. The user-friendly interface maintains the simplicity that surgeons appreciate, thus providing greater analytical power under the hood. Surgeons who have employed MarginProbe report that they can now make intraoperative decisions with immediate access to margin status.
In a longer view of the healthcare system, the introduction of MarginProbe 2 in the U.S. is indicative of growing demand to focus on precision-based surgical services. MarginProbe 2 would make Dilon Technologies the leader in intraoperative diagnostic innovations. Additionally, the current trend toward personalized and minimally invasive methods is likely to increase demand for MarginProbe 2 in the coming years.
Executive Statement
George Makhoul, Chief Executive Officer of Dilon Technologies, emphasized the patient-focused mission behind the new system, stating, “MarginProbe 2 is a game-changer for breast surgery. By providing surgeons with immediate, reliable margin information, we are helping reduce re-excision rates and improve the overall surgical experience for both patients and healthcare providers. No one wants to return for a second operation, and our goal is to help surgeons achieve clear margins the first time.”