Dune Medical Devices won European regulatory approval for the latest generation of its breast cancer detection tool, the MarginProbe System Type 1.2 console.
Dune Medical Devices Inc.
Framingham, Mass.-based Dune Medical Devices finally got the FDA nod for its MarginProbe breast cancer tissue detection system, a device that can help surgeons determine whether they have excised all the cancerous tissue during early-stage breast cancer surgery.
The approval was based on a 664 patient study evaluating the MarginProbe’s ability to identify cancerous tissue along the edges of removed breast tissue during early lumpectomy procedures.
Framingham, Mass.-based Dune Medical Devices inched closer to premarket approval from the FDA for its MarginProbe breast cancer detection tool, winning an "approvable letter" from the federal watchdog agency.
The company is working together with the FDA on the design of the required post approval study for the MarginProbe system, the final step before Dune can commercialize the product in the U.S., according to the approvable letters.
Following a thumbs-up for its first-of-a-kind MarginProbe breast cancer detection device last week, Dune Medical Devices is promising to work closely with FDA to complete the approval process and plans an immediate U.S. launch should the watchdog agency give it a green light.
The FDA’s general & plastic surgery devices committee met June 21 in Gaithersburg, Md., to mull whether the device, which uses electromagnetic waves to identify possibly cancerous tissue on the edges of a breast tumor, ought to be approved for the U.S. market.
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An FDA advisory panel recommended approval for Dune Medical Devices‘ MarginProbe breast cancer detection device today.
The federal watchdog agency’s general & plastic surgery devices advisory panel met to mull whether the device, which uses electromagnetic waves to identify possibly cancerous tissue on the edges of a breast tumor in real time during surgical procedures, ought to be approved for the U.S. market.
Dune Medical Devices has a date with the FDA to review its pre-market approval application for the MarginProbe breast cancer detection device.
The watchdog agency’s general & plastic surgery devices advisory panel scheduled a hearing for June 21 to review the PMA data for the device, which uses electromagnetic waves to characterize human tissue in real time and "provides intra-operative information on the malignancy of the surface of the ex vivo lumpectomy specimen," according to the FDA.
Dune Medical Devices Inc. announced interim results from a study using its MarginProbe system in breast-conserving surgery for tumor removal.
The study’s findings established that use of the device during surgery to remove ductal carcinoma contributes to a 50 percent reduction in the necessity for additional procedures to remove residual cancer.