Healthcare Equipment and Supplies
Company Overview of Dune Medical Devices Ltd.
Dune Medical Devices Ltd. develops tissue characterization technology that provides surgeons and radiologists the ability to detect cancer in real time. It offers MarginProbe System, a technology that delivers real-time assessment on excised tissue in breast cancer surgery. The company was founded in 2002 and is based in Caesarea, Israel with additional offices in the United States and Israel.
20 Alon Hatavor Street
Industrial Park South
Founded in 2002
Key Executives for Dune Medical Devices Ltd.
Founder, Chief Executive Officer and Director
Chief Operation Officer and General Manager
Compensation as of Fiscal Year 2016.
Dune Medical Devices Ltd. Key Developments
Dune Medical Devices Receives Pre-Market Approval from the U.S. Food and Drug Administration to Make Modifications to MarginProbe 1.2
Mar 23 16
Dune Medical Devices has received Pre-Market Approval (PMA) from the U.S. Food and Drug Administration (FDA) to make modifications to MarginProbe 1.2, a breast cancer surgical device developed by the company. Once completed, version 1.2R of MarginProbe, the only FDA approved device for real-time detection of cancer in breast conserving surgery, will incorporate new features that will enable the device to be complaint with the recent changes in Restriction of Hazardous Substances (RoHs) requirements necessary to sell into the European Union (EU) market. The new upgrade includes manufacturing MarginProbe 1.2 to meet changes in the RoHs requirements - which are expected to be adopted by the U.S. in the near future. In addition, Dune Medical Device equipped the instrument with a new, updated screen for displaying the results and an upgraded operating system. MarginProbe 1.2R also contains a much stronger and more modern CPU Unit allowing the medical device to support anticipated evolutions in both technology and operating systems. Traditionally, one in four women who undergo a lumpectomy procedure require a re-excision to remove cancer missed during the first procedure. That number is reduced by 51% when MarginProbe is used during the initial procedure. The device has been receiving attention of breast cancer surgeons across the globe. Most recently, MarginProbe was featured during a seminar at the Miami Breast Cancer Conference by J. Michael Dixon, MD, Western General Hospital, Clinical Director, Breakthrough Breast Cancer Research Unit and Honorary Professorship in Breast Surgery, University of Edinburgh.
Dune Medical Devices Announces FDA Approval of Updated Version of MarginProbe
Jan 5 15
Dune Medical Devices announced FDA approval of an updated version of its product, MarginProbe, a medical device that enables real-time detection of cancer at the surface of excised tissue specimens during breast-conserving cancer surgery. Surgeon feedback, innovative design ideas, and superior miniaturization engineering were the driving forces behind the development of MarginProbe 1.2. This new version, which utilizes the same trusted, FDA-approved, diagnostic technology as version 1.1, is focused on proving superior functionality, portability, and overall ease of use. Feature enhancements for MarginProbe 1.2 include: onReduced Size & Weight: A major highlight of MarginProbe 1.2 is the reduced size. The new unit is in tabletop form (29 x 43 x 38 cm in size) and weighs 35 lbs. making it 75% lighter and much easier to handle in busy operating rooms. onBrighter Screen: The screen's brightness has been enhanced to provide surgeons a clearer screen image. onWider Viewing angle: With MarginProbe 1.2, surgeons will have the ability to clearly view the screen from anywhere in the operating room without encountering a glare, pixilation, or a blind spot. onImproved on-screen notices: Ensuring key alerts are easier to notice in the OR ambiance. onStartup Time Reduced 50%: The startup time for MarginProbe 1.2 is reduced from approximately three minutes to 90 seconds, making MarginProbe's services even more instantaneous. onImproved service time: Due to its new reduced size, technicians are able to provide faster service, reducing down time in case service is needed.
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