Dilon Applied sciences Launches FDA-Authorized MarginProbe® 2 for Intraoperative Margin Evaluation


NEWPORT NEWS, Va., Dec. 15, 2025 /PRNewswire/ — Dilon Applied sciences, a number one supplier of medical units, has gained FDA approval for its MarginProbe® 2 system and is asserting its launch within the U.S. That is the next-generation system for real-time intraoperative margin evaluation in breast most cancers surgical procedure. MarginProbe® 2 is designed to assist surgeons obtain better precision throughout breast-conserving surgical procedures, decreasing the necessity for added procedures and bettering affected person outcomes.

This builds on the confirmed success of the unique MarginProbe®, the one real-time margin evaluation system in the marketplace with a strong library of printed information proven to cut back re-excisions by over 54% on common.  The brand new system, developed by Dilon’s staff in Israel, gives elevated sensitivity on all tumors with an array of miniaturized sensors, enhanced detection algorithms, and seamless integration into the working room workflow, permitting surgeons to make important choices with confidence whereas within the OR. 

The sensitivity has elevated to over 76% on all specimens which was reported out within the pivotal research performed within the U.S.  Surgeons can now choose an choice to have MarginProbe® detect most cancers by selecting DCIS (ductal carcinoma in-situ) or Invasive.  DCIS accounts for 31% of re-excisions in ladies ages 18-64 and 24% in ladies over the age of 65 based on a current research printed within the Annals of Surgical Oncology1. The workflow of MarginProbe® is appropriate with any hospital setting and the easy to make use of interface is maintained on this subsequent technology. 

“MarginProbe® 2 is a game-changer for breast surgical procedure,” mentioned George Makhoul, CEO of Dilon Applied sciences. “By offering surgeons with quick, dependable margin info, we’re serving to cut back re-excision charges and enhance the general surgical expertise for each sufferers and healthcare suppliers. Nobody needs to have to return again for a reoperation.  Our aim is to ensure surgeons can get it the primary time.”

MarginProbe® customers proceed to spotlight the impression of the know-how:

  • “Inside 3-5 minutes I’ve quick, binary outcomes of optimistic or detrimental margins on my specimen. I can decide for my affected person in actual time which has helped me preserve my 4.6% re-excision fee,” based on Dr. Vincent Reid from Mercy Hospital in Cedar Rapids, IA.
  • “MarginProbe® is simple to make use of within the OR and provides minimal time to the process. The system gives outcomes which are straightforward to interpret and apply in actual time for intraoperative lumpectomy margin evaluation. The training curve is brief, and the MarginProbe® could be utilized in any apply setting to assist breast conserving surgical procedure.,” said Dr. Freya Schnabel from NYU Langone.
  • Dr. Jaime Alberty from NYC Well being and Hospitals System has lauded, “The modifications made on this system to enhance the sensitivity with out sacrificing specificity are spectacular. DCIS is a serious ache level in our re-excisions and something we will reliably use to cut back that shall be used.”

The U.S. launch of MarginProbe® 2 displays Dilon’s dedication to advancing patient-first applied sciences that assist extra exact care and improved medical outcomes. Dilon’s strong business staff shall be showcasing the know-how nationwide.  Hospitals and breast surgeons can go to www.dilon.com for extra info. 

About Dilon Applied sciences

Dilon Applied sciences Inc., a medical system producer, based mostly in Newport Information, Virginia, strives to enhance the standard of life by offering a variety of modern medical options that profit sufferers world wide. Dilon has a robust medical system portfolio; HEMOBLAST Bellows®, the one mixture powdered hemostat that incorporates collagen, thrombin and chondroitin sulfate; the Navigator™ 2.0 System, a trusted model and world-renowned surgical gamma probe for radio-guided lymphatic mapping and tumor localization, the MarginProbe®, a groundbreaking know-how for correct margin evaluation in breast most cancers surgical procedure, and the CoPilot, an modern, transportable, and simple to make use of video laryngoscope. For extra info, go to www.dilon.com.

1.    Kim Y, Ganduglia-Cazaban C, Tamirisa N, Lucci A, Krause TM. Modern Evaluation of Reexcision and Conversion to Mastectomy Charges and Related Healthcare Prices for Ladies Present process Breast-Conserving Surgical procedure. Ann Surg Oncol. 2024 Feb 6. doi: 10.1245/s10434-024-14902-z.

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