FDA approves Lumisight™ for breast cancer fluorescence imaging after lumpectomy, aiding residual cancer detection with 84% accuracy.

The FDA has approved Lumisight™ (pegulicianine), a drug-device combination, for fluorescence imaging in adults with breast cancer after tumor removal during lumpectomy surgery. The optical imaging agent is used with the Lumicell Direct Visualization System or another fluorescence imaging system approved for use with pegulicianine, helping detect residual cancer with an 84% diagnostic accuracy, potentially reducing the need for additional surgeries.