DUNE MEDICAL DEVICES MARGINPROBE SYSTEM
Overview
The DUNE MEDICAL DEVICES MARGINPROBE SYSTEM, developed by Dilon Medical Technologies, is an innovative intraoperative tissue assessment tool designed for use during breast-conserving surgery. It utilizes radiofrequency (RF) spectroscopy to provide real-time identification of cancerous tissue at the margins (≤ 1mm) of excised lumpectomy specimens. This technology aims to significantly improve surgeons’ ability to achieve clear margins in the initial operation, thereby reducing the need for repeat surgeries and improving patient outcomes. The system consists of a console and a disposable handheld probe that delivers RF signals to the tissue and analyzes the reflection, providing immediate visual and audible feedback to the surgeon.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Real-time intraoperative margin assessment
- Utilizes radiofrequency (RF) spectroscopy
- Identifies cancerous tissue at margins (u2264 1mm) of excised lumpectomy specimens
- Reduces re-excision rates in breast-conserving surgery
- Provides immediate feedback to surgeons (visible and audible output)
- Comprised of a console and a disposable handheld probe
- Non-invasive application on excised tissue
- Effective in identifying both DCIS and invasive cancers (MarginProbe 2)
- Features enhanced detection algorithms (MarginProbe 2)
- User-friendly interface for seamless operating room integration
Use Cases
- Intraoperative margin assessment during breast lumpectomy surgery
- Reducing the need for repeat surgeries in breast cancer patients
- Assessing margins for previously diagnosed breast cancer
- Identifying cancerous tissue (including DCIS and invasive cancers) on the surface of excised breast tissue
What Physicians Need to Know
The MarginProbe System, particularly MarginProbe 2 with its enhanced detection algorithms, serves as a valuable *adjunctive* tool for real-time margin assessment in breast-conserving surgery. While it significantly reduces re-excision rates, remember it complements, rather than replaces, traditional histopathology. Be aware of the potential for false positives, which may lead to the removal of additional healthy tissue, but weigh this against the substantial benefit of reducing repeat surgeries and improving patient peace of mind. Leverage the immediate feedback to guide intraoperative decisions and strive for clear margins in the initial procedure.
The MarginProbe System is a self-contained medical device designed for direct use in the operating room. Its integration primarily involves fitting into the existing surgical workflow alongside standard methods like imaging and palpation. There are no explicit mentions of deep electronic medical record (EMR) or other hospital IT system integrations. Its portability and quick results facilitate its use within the current operating room environment. Dilon Technologies also offers other surgical devices, suggesting a potential for a complementary suite of tools within a surgical setting.
Details
| Category | Oncology AI, Surgical AI |
| Pricing | Console: $50,000; disposable probe: $995 per procedure — Console: $50,000 (one-time cost); Disposable probe: $995 per procedure. |
| Deployment | On-premise (console and probe used in the operating room) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The original MarginProbe System received Premarket Approval (PMA) from the FDA on December 27, 2012 (P110014). It is indicated as an adjunctive diagnostic tool for identifying cancerous tissue at the margins (≤ 1mm) of ex-vivo lumpectomy specimens during intraoperative use in patients undergoing lumpectomy for previously diagnosed breast cancer. Version 1.2 received FDA clearance in January 2015, and the next-generation MarginProbe 2 system received FDA approval and launched in the U.S. in December 2025. |
| Integrations | |
| EHR | Not specified |
| Specialties | General Surgery, Oncology, Pathology |
What the Web Says
The DUNE MEDICAL DEVICES MARGINPROBE SYSTEM, now part of Dilon Technologies, is an FDA-approved intraoperative tool designed to help surgeons identify cancerous tissue at the margins of excised breast tissue during lumpectomy procedures. It uses radiofrequency spectroscopy to provide real-time assessment, aiming to reduce the need for repeat surgeries. Physicians generally express positive opinions, highlighting its ability to improve surgical outcomes and provide peace of mind to both surgeons and patients.
Overall: PositiveStrengths
- Significantly reduces re-excision rates in breast-conserving surgery, with studies showing reductions ranging from 51% to 75%.
- Provides real-time, intraoperative margin assessment, allowing surgeons to make immediate decisions and remove additional tissue if needed.
- Helps achieve clear margins in the initial lumpectomy, reducing patient anxiety and the emotional burden of repeat surgeries.
- Can lead to less tissue removed overall by enabling targeted shaving of positive margins.
- Effective for both invasive and DCIS (Ductal Carcinoma In-Situ) breast cancers.
- User-friendly interface and compatible with any hospital setting.
Limitations
- Can be expensive, with the system costing around $20,000 and each disposable probe approximately $1,000.
- May produce false positives, leading to the removal of healthy tissue, which can have cosmetic implications.
- Some studies indicate variability in diagnostic accuracy, with sensitivity ranging from 66.7% to over 90% and specificity from 47.5% to 87%.
- Not universally adopted, and some institutions may have other methods for detecting cancer at the margins.
- Long-term outcomes, such as recurrence rates, have not always been reported in studies.
Based on reviews from: Dilon Technologies, CURE, Globes English - u05d2u05dcu05d5u05d1u05e1, Healthcare Dive, PMC - NIH, FDA, BioSpace, Precedence Research, PR Newswire, INAHTA, YouTube, Imaging Technology News, eBay, accessdata.fda.gov, BJS | Oxford Academic
Last updated: 2026-07-17
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