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Dune Medical lands conditional approval for MarginProbe breast cancer screening tool

Mon, 11/19/2012 - 12:59pm
Mass Device

The FDA awards Dune Medical Devices' MarginProbe breast cancer detection system an "approvable letter," with full approval pending final agreement on post-approval study design.

Dune Medical Devices logo

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.

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