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Lumicell earns positive FDA panel decision on surgical imaging tool, approval decision expected soon

Lumicell announced that an FDA advisory committee voted in support of the benefit-risk profile of its LumiSight offering.

LumiSight, an optical imaging agent, works in combination with the Lumicell direct visualization system (DVS) in breast cancer imaging. The combination product — a fluorescence-guided surgical imaging tool — detects residual cancer in real-time during a lumpectomy.

Lumicell’s system enables real-time assessments of the breast cavity to remove residual cancer tissue. Such tissue would otherwise have been missed, according to Dr. Shelly Hwang. In a news release, Hwang, leader of Duke University’s Breast Oncology Program, said it’s “unlike any other surgical tool available” today.

The FDA’s Medical Imaging Drugs Advisory Committee (MIDAC) voted 16-2 in favor of LumiSight. One voter abstained.

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