Soft-tissue tumor locator wins breakthrough device status
A cancer treatment product developed by Merit Medical Systems of South Jordan, Utah, has been designated a breakthrough device by the FDA.
Called Scout MD, the offering is a localization system for surgeons excising tumors of the breast or other soft tissues.
The product works by pinpointing tumor location and margins using up to four implantable reflectors.
The reflectors guide excision by revealing localization in multiple dimensions, which helps the surgeon access the whole tumor while avoiding healthy tissue, according to an announcement posted Feb. 16.
Merit says the product will expand the company’s Scout portfolio, which consists of various tools and aids for operating on soft-tissue cancers.
The company cites a 2019 study showing that around 1 of every 5 women who undergo lumpectomy need a second surgery.
“Localization procedures help surgeons precisely target breast cancer, which may result in more successful surgeries and improved patient outcomes,” Merit points out.
Merit Medical was founded in 1987 and focuses on manufacturing and distributing disposable medical devices used in cardiology, radiology, oncology, critical care and endoscopy.