Dune Medical Devices won European regulatory approval for the latest generation of its breast cancer detection tool, the MarginProbe System Type 1.2 console.
The MarginProbe device helps surgeons determine whether they have excised all the cancerous tissue during early-stage breast cancer surgery. The system has proven in clinical trials to be more effective than traditional methods in identifying cancerous remnants along the edges of removed breast tissue during lumpectomy procedures.
The new model of the device features elements that streamline manufacturing and lower manufacturing costs for the system. The system also incorporates a more compact size and more aesthetic appearance, according to the company.
"This new and improved version of the MarginProbe System allows easier transport for our customers and for our sales representatives and we believe will help to expand the use of MarginProbe in more and more breast surgery cases in the EU," DEO Dan Levangie said in prepared remarks.
Dune Medical is on a bit of a roll, having just last month won FDA approval for its MarginProbe system. That regulatory win marked a significant milestone, and precipitated a shift in company headquarters from Israel to Framingham, Mass., in order to start developing a sales team and commercial strategy.
The MarginProbe system has been on the European market since 2008, and initially submitted the device for U.S. regulatory approval in April 2011.