January 2, 2013 by MassDevice staff
Dune Medical finally wins full FDA pre-market approval for its MarginProbe intra-operative tool for assessing tissue during early-stage breast cancer surgery.
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.
The device proved to be 3 times more effecting in finding such cancers compared to traditional intra-operative imaging and assessments, according to a press release.
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The MarginProbe system uses electromagnetic waves to identify possibly cancerous tissue on the edges of a breast tumor in real time during surgical procedures, and is the company's 1st commercial product.
Physicians using MarginProbe may be able to better identify lingering cancerous tissue during surgery, reducing the number of repeat procedures needed to remove additional cancerous cells detected at the edge of the removed tissue, according to Dune.