Dune Medical Devices Inc. has announced that the US Food and Drug Administration (FDA) has formally accepted the company's premarket approval (PMA) application for its MarginProbe System breast cancer screening device. The company expects to receive a response in a few months.
The MarginProbe can scan the edges of breast tumors that have been surgically removed, as well as the margins of the incision to ensure that they are cancer free. Under current procedures, doctors use imaging devices to locate a tumor, and excise large areas of the breast to ensure the tumor's complete removal.
Dune Medical says that re-excision procedures are currently necessary in up to 30% of patients
The MarginProbe aims to eliminate the need for new biopsies and repeat surgeries, and eliminates the need to remove large areas of breast tissue.
The FDA stated that it believes that the MarginProbe represents a breakthrough technology that may offer a clinically meaningful advantage, and, since there is no legally marketed alternative device, it granted the PMA application expedited review.
In late April, Dune Medical announced the results of a clinical trial of the MarginProbe on 664 women who had breast tumors removed. The company said that the device tripled doctors' ability to diagnose conditions in which cancer tissue remained in the body, thereby reducing by 57% the need for repeat surgery.
Published by Globes [online], Israel business news - www.globes-online.com - on May 19, 2011
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