Dune Medical lands FDA approval for breast cancer tissue detector
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 .