Dune gets FDA panel nod for breast cancer detector

Maryland's Dune Medical Devices won a 10-1 vote from an FDA advisory panel on MarginProbe, the company's breast cancer surgery aid. The device is designed to minimize the need for repeat operations after breast-conservation surgeries by detecting the presence of cancer at or near the surface of excised tissue. In a trial of 600 patients, Dune found that MarginProbe significantly reduced the rate of follow-up surgeries, the company said. The device is already available in Europe, and, after filing a PMA with the FDA in 2011, the company expects to get MarginProbe on U.S. shelves soon. Release | More

Suggested Articles

The respiratory care company Vyaire Medical has brought on a new CEO, Gaurav Agarwal, following a year of new product launches.

Precision oncology firm Notable Labs is launching its first self-sponsored clinical trial, designed from the ground up to help validate its platform.

Inotrem and Roche’s diagnostics division have upgraded their years-long collaboration on a plasma test for septic shock, with a new worldwide deal.