MarginProbe Alteration Gains Pre-market Approval

March 24, 2016

The FDA has granted Dune Medical Devices pre-market approval to make manufacturing changes to its FDA-approved MarginProbe 1.2 breast conserving device, intended for patients undergoing lumpectomies.

New modifications will include a refined screen for displaying results, an updated operating system and CPU unit.

When used in the initial procedure, the device reduces the need for re-excision by 51 percent, the company says

The new changes will allow the device to align itself with updated Restriction of Hazardous Substances requirements. — Anisa Jibrell