The US Food and Drug Administration (FDA) has granted approval for Dilon Technologies’ MarginProbe 2, a next-generation intraoperative margin assessment device for use in breast cancer surgery, enabling its American launch.
The device is intended to assist surgeons during breast-conserving surgery, to decrease repeat procedures and enhance outcomes for patients.
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It builds upon the original MarginProbe, which is already in use for margin assessment in real-time.
Developed by the company’s Israel-based team, the new system features an array of miniaturised sensors and detection algorithms.
It is designed to integrate smoothly into the operating room workflow and allows surgeons to make decisions during procedures.
According to a pivotal study carried out in the US, the device’s sensitivity has been reported at more than 76% on all specimens.
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By GlobalDataNow, surgeons can choose to have MarginProbe 2 detect either ductal carcinoma in situ (DCIS) or invasive cancer.
MarginProbe 2 is said to maintain a simple interface and is compatible with any hospital setting.
Dilon Technologies CEO George Makhoul said: “MarginProbe 2 is a game-changer for breast surgery. By providing surgeons with immediate, reliable margin information, we’re helping reduce re-excision rates and improve the overall surgical experience for both patients and healthcare providers.
“No one wants to have to come back for a reoperation. Our goal is to make sure surgeons can get it the first time.”
Dilon noted that the US launch of the system reflects its focus on advancing patient-first solutions supporting clinical outcomes and care.
The company’s medical device portfolio includes HEMOBLAST Bellows, a combination powdered haemostat; the Navigator 2.0 System, a surgical gamma probe for radio-guided lymphatic mapping and tumour localisation; and CoPilot, a portable video laryngoscope.
