Dilon Technologies Announces FDA Approval and U.S. Launch of MarginProbe® 2, Next-Generation Intraoperative margin assessment technology

NEWPORT NEWS, Va., Dec. 15, 2025 /PRNewswire/ -- Dilon Technologies, a leading provider of medical devices, has gained FDA approval for its MarginProbe^® 2 system and is announcing its launch in the U.S. This is the next-generation device for real-time intraoperative margin assessment in breast cancer surgery. MarginProbe^® 2 is designed to help surgeons achieve greater precision during breast-conserving surgeries, reducing the need for additional procedures and improving patient outcomes.

This builds on the proven success of the original MarginProbe^®, the only real-time margin assessment device on the market with a robust library of published data shown to reduce re-excisions by over 54% on average.  The new system, developed by Dilon's team in Israel, provides increased sensitivity on all tumors with an array of miniaturized sensors, enhanced detection algorithms, and seamless integration into the operating room workflow, allowing surgeons to make critical decisions with confidence while in the OR. 

The sensitivity has increased to over 76% on all specimens which was reported out in the pivotal study conducted in the U.S.  Surgeons can now select an option to have MarginProbe^® detect cancer by choosing DCIS (ductal carcinoma in-situ) or Invasive.  DCIS accounts for 31% of re-excisions in women ages 18-64 and 24% in women over the age of 65 according to a recent study published in the Annals of Surgical Oncology¹. The workflow of MarginProbe^® is compatible with any hospital setting and the simple to use interface is maintained in this next generation. 

"MarginProbe^® 2 is a game-changer for breast surgery," said George Makhoul, CEO of Dilon Technologies. "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."

MarginProbe^® users continue to highlight the impact of the technology:

• "Within 3-5 minutes I have immediate, binary results of positive or negative margins on my specimen. I can make a decision for my patient in real time which has helped me maintain my 4.6% re-excision rate," according to Dr. Vincent Reid from Mercy Hospital in Cedar Rapids, IA.
• "MarginProbe^® is straightforward to use in the OR and adds minimal time to the procedure. The device provides results that are easy to interpret and apply in real time for intraoperative lumpectomy margin assessment. The learning curve is short, and the MarginProbe^® can be utilized in any practice setting to support breast conserving surgery.," stated Dr. Freya Schnabel from NYU Langone.
• Dr. Jaime Alberty from NYC Health and Hospitals System has lauded, "The changes made in this system to improve the sensitivity without sacrificing specificity are impressive. DCIS is a major pain point in our re-excisions and anything we can reliably use to reduce that will be used."

The U.S. launch of MarginProbe^® 2 reflects Dilon's commitment to advancing patient-first technologies that support more precise care and improved clinical outcomes. Dilon's robust commercial team will be showcasing the technology nationwide.  Hospitals and breast surgeons can visit www.dilon.com for more information. 

About Dilon Technologies

Dilon Technologies Inc., a medical device manufacturer, based in Newport News, Virginia, strives to improve the quality of life by providing a wide range of innovative medical solutions that benefit patients around the world. Dilon has a strong medical device portfolio; HEMOBLAST Bellows^®, the only combination powdered hemostat that contains collagen, thrombin and chondroitin sulfate; the Navigator™ 2.0 System, a trusted brand and world-renowned surgical gamma probe for radio-guided lymphatic mapping and tumor localization, the MarginProbe^®, a groundbreaking technology for accurate margin assessment in breast cancer surgery, and the CoPilot, an innovative, portable, and easy to use video laryngoscope. For more information, visit www.dilon.com.

^1.    Kim Y, Ganduglia-Cazaban C, Tamirisa N, Lucci A, Krause TM. Contemporary Analysis of Reexcision and Conversion to Mastectomy Rates and Associated Healthcare Costs for Women Undergoing Breast-Conserving Surgery. Ann Surg Oncol. 2024 Feb 6. doi: 10.1245/s10434-024-14902-z.

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SOURCE Dilon Technologies