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news.Dune Medical Devices has launched a pivotal clinical trial of the MarginProbe intraoperative, real-time, positive margin detection system, following the FDA investigational device exemption approval of its protocol during breast cancer surgery.
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With the FDA investigational device exemption (IDE) approval in place, Dune is launching a nationwide US clinical trial of MarginProbe, which uses radio frequency spectroscopy to characterize breast tissue during surgery to determine the malignancy status of tumor margins.
The Dune MarginProbe system comprises a sterile hand-held probe and portable console. When the probe tip is applied to an excised lumpectomy segment, radio frequency signals are transmitted into the tissue and reflected back to the console, where they are analyzed using a specialized algorithm to determine tissue status. With streamlined operation and instantaneous results, the technology is designed for easy integration into existing surgical workflow, the company said.
Dan Hashimshony, founder and CEO of Dune Medical Devices, said: “Based on the strength of our ongoing studies and their validation of the benefits of MarginProbe, we look forward to the device’s acceptance within the surgical community. Soon thereafter, we hope to help ease the difficulties experienced by women who receive multiple surgeries for breast cancer.”