The system, an adjunct to current standard methods of intraoperative surgical margin assessment, is intended to enable real-time detection of cancer at or near the surface of excised tissue specimens during breast cancer surgery.
“We are very pleased with the panel’s positive decision on the MarginProbe System for use in the United States,” says Dune’s CEO Dan Levangie, in the release. “We believe that the MarginProbe System will give surgeons a powerful tool in their fight against breast cancer and provide women a substantially better chance of avoiding additional surgeries. We will work closely with the FDA to complete the approval process and intend to launch the MarginProbe System in the United States immediately thereafter.”
Dune Medical Devices has offices in the United States, Israel and Switzerland.
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