The Medical Imaging Drugs Advisory Committee (MIDAC) has voted in support of the benefit-risk profile of Lumisight.
During a March 5 meeting, MIDAC members voted 16 to 2 in favor of the company’s recent new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its Lumisight optical imaging agent for breast cancer and a premarket approval application (PMA) for the company's direct visualization system.
The company’s combined product is an intracavity, fluorescence-guided surgical imaging tool used to detect residual cancer in real-time during lumpectomy surgery, also known as breast-conserving surgery.
MIDAC provides independent advice to support FDA decision-making, with the FDA now expected to make a decision on the company's NDA and PMA in the near future, Lumicell noted.
