The U.S. Food and Drug Administration (FDA) has accepted for review Lumicell's new drug application for its Lumisight optical imaging agent for breast cancer and a premarket approval application for the company's direct visualization system.
Lumisight and Lumicell Direct Visualization help clinicians assess the lumpectomy cavity of the breast, according to Lumicell. The company's direct visualization system consists of a handheld imaging probe that can be inserted into the breast cavity and cancer detection software to identify residual disease.
The applications are supported by data from more than 700 breast cancer patients; clinical results regarding the performance of Lumisight and Lumicell DVS have been published in NEJM Evidence and JAMA Surgery.
