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SOUTH JORDAN, Utah – Merit Medical Systems , Inc. (NASDAQ: NASDAQ:), a healthcare technology company, announced that it has received FDA 501(k) clearance for its SCOUT MD surgical guidance system. This system is designed to improve the precision of surgeries for breast and other soft tissue tumors by allowing the implantation of up to four different reflector configurations to target tumor locations.
The SCOUT MD System aims to facilitate more accurate excisions while minimizing damage to surrounding healthy tissue. This could potentially reduce the likelihood of patients requiring re-excision, which is a second surgery often required when initial margins are unclear. According to breast surgical oncologist Dr. John Vincent Kiluk, the new technology allows surgeons to better delineate the edges of the resection, which should improve the ability to achieve adequate margins on larger tumors.
Merit’s introduction of the SCOUT MD surgical guidance system expands its oncology portfolio, which includes the SCOUT radar tracking system and the SAVI Brachy system. The company’s focus on innovation is highlighted by the deployment of more than 500,000 devices for patient procedures starting in January 2024, gathering real-world evidence to improve cancer care.
The development of SCOUT MD is particularly significant given that breast cancer is the most common cancer globally, with approximately 2.3 million women diagnosed in 2020. Lumpectomy, a common treatment option, leads to repeat surgeries in 20%-30% of cases due to inadequate margins from the initial surgery.
Merit Medical, founded in 1987, specializes in the development, manufacturing and distribution of disposable medical devices for various medical procedures, including cardiology, radiology and oncology. The company employs approximately 7,000 people worldwide and is committed to continuous innovation in healthcare technology to improve patient experiences and outcomes.
This announcement is based on a press release from Merit Medical Systems, Inc.
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