MedTech DiveFDA Approves Lumicell’s Breast Cancer Imaging Tool

FDA’s Approval of Lumicell’s Imaging Tool Enhances Surgical Precision in Breast Cancer Treatment

The FDA has recently approved Lumicell’s innovative imaging technology designed for use during breast cancer surgeries. This tool, aimed at reducing the rate of re-excision by improving the detection of residual cancer tissues, marks a significant advance in surgical procedures. It leverages a unique combination of a fluorescent molecule and a handheld detection device to facilitate real-time imaging and analysis, enhancing the accuracy of tumor removal during lumpectomies.

Key Points:

• The FDA has granted approval to Lumicell’s breast cancer imaging technology, known as the Lumisystem, which comprises two components: Lumisight and Lumicell DVS.
• Lumisight is a fluorescent molecule that reacts to specific enzymes prevalent near tumor cells, aiding in the identification of residual cancer by emitting a fluorescent signal.
• The Lumicell DVS component includes a handheld probe and a sophisticated tumor detection algorithm, enabling surgeons to illuminate the breast cavity and visually analyze tissue for residual cancer cells in real time.
• This technology received FDA approval after a positive recommendation from an FDA advisory committee, which voted 16-2 in favor of its benefits over its associated risks.
• Clinical trials demonstrated the Lumicell system’s efficacy, with results meeting prespecified thresholds for tumor removal and specificity, though it slightly fell short on sensitivity goals.
• Approximately 36% of patients currently undergo a second surgery post-lumpectomy due to inadequate removal of all cancerous tissue; this tool aims to significantly reduce this number.
• The system’s development was supported by data from a prospective clinical trial involving around 400 patients, comparing standard care to those using the Lumicell device.

“Our most common surgical procedure to treat these women is lumpectomy. Unfortunately, the intraoperative tools we have are limited and do not identify the extent of tumor accurately enough, making it challenging to achieve a complete tumor resection.”
– Kelly Hunt, MD Anderson Cancer Center

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