Merit Medical gets FDA nod for new cancer surgery system

SOUTH JORDAN, Utah – Merit Medical Systems , Inc. (NASDAQ: NASDAQ:), a healthcare technology company, has announced receiving 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 cancers by enabling the implantation of up to four different reflector configurations to pinpoint tumor locations.

The SCOUT MD system aims to facilitate more accurate excisions while minimizing damage to surrounding healthy tissue. This could potentially decrease the likelihood of patients needing re-excision, which is a second surgery often required when initial margins are not clear. According to Dr. John Vincent Kiluk, a Breast Surgical Oncologist, the new technology allows surgeons to delineate the edges of resection better, which should improve the ability to obtain adequate margins on larger tumors.

Merit’s introduction of the SCOUT MD Surgical Guidance System expands its oncology portfolio, which includes the SCOUT Radar Localization System and the SAVI Brachy System. The company’s focus on innovation is underscored by its distribution of over 500,000 devices for patient procedures as of January 2024, gathering real-world evidence to enhance oncology care.

The development of SCOUT MD is particularly significant given that breast cancer is the most prevalent cancer worldwide, with an estimated 2.3 million women diagnosed in 2020. Lumpectomy, a common treatment option, leads to repeat surgeries in 20% to 30% of cases due to inadequate margins from the initial surgery.

Merit Medical, founded in 1987, specializes in the development, manufacture, and distribution of disposable medical devices for various medical procedures, including cardiology, radiology, and oncology. The company employs around 7,000 people globally and is dedicated to continuing innovation in healthcare technology to enhance patient experiences and outcomes.

This announcement is based on a press release statement from Merit Medical Systems, Inc.

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