PAOLI, Pa., March 23, 2016 /PRNewswire/ -- 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.
"We are continuing to listen to our customers by investing in technology to enhance MarginProbe," said Dan Hashimshony, PhD, CEO and founder of Dune Medical Devices. "Once completed, these changes will enable Dune Medical Device to continue to develop products that will improve the standard of care in breast conserving surgery and allow physicians and patients to be confident that 'they got it all' in the first surgery."
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 percent 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. The presentation, entitled Intraoperative Margin Assessment, addressed the ongoing concern among surgeons who ask, "Did I get it all?" when performing breast conserving surgeries.
"This is an exciting time for the company as we continue to expand our presence in the market and our technology platforms," Hashimshony added, "It speaks to the tenacity of our team and the dedication we have as a company to improve the outcomes and experience for patients during a very difficult time in their lives."
About Dune Medical Devices
Dune Medical Devices was founded in 2002 by Dr. Dan Hashimshony to realize the extraordinary medical potential of its proprietary tissue characterization technology. Offering surgeons and radiologists the real time ability to identify cancerous tissues and react immediately, this technology holds the promise for a broad range of surgical and diagnostic applications.
Dune Medical Devices is a privately held company with offices in the U.S. and Israel. For more information, please visit www.dunemedical.com.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/marginprobe-modification-receives-fda-pre-market-approval-300240332.html
SOURCE Dune Medical Devices