Lumicell Receives FDA Approval for LumiSystem™ Imaging Platform to Illuminate Residual Breast Cancer

Lumicell has received the US FDA New Drug Application (NDA) approval for its LUMISIGHT™ optical imaging agent and its Premarket Approval (PMA) application for Lumicell™ Direct Visualization System (DVS), together referred to as LumiSystem™, which enables surgeons to scan the breast cavity post-lumpectomy in real-time to detect and resect residual cancer with 84% diagnostic accuracy.

The LumiSystem combination is indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.

We believe this is the first drug-device combination product approved in over a decade to have followed both of the FDA’s most stringent NDA and PMA review processes. With the FDA’s approval, LumiSystem is now the first and only imaging combination product capable of detecting cancerous tissue where it matters most, inside the breast cavity,” said Howard Hechler, President and Chief Operating Officer of Lumicell.

To view the source version, please click HERE.

en_GBEnglish (UK)