Merit’s Scout MD Surgical Guidance System Gets Breakthrough Device Status

Merit Medical’s Scout MD Surgical Guidance System has gained FDA’s Breakthrough Device designation for pinpointing exact locations of tumors in abnormal breast and other soft tissues.

The system supports implantation of up to four reflectors which allow more precise excision, “minimizing trauma to healthy tissue and helping to reduce the likelihood of re-excision and the emotional and physical pain associated with a second surgery,” the company said.

Breast cancer patients who undergo lumpectomy procedures could benefit from the device as up to 30 percent of those who go through lumpectomy need a repeat surgery to remove additional tumor tissue.

The Breakthrough Device status allows for more timely access to technologies that could provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.