Lumicell’s imaging platform gains US FDA Approval to Detect Residual Breast Cancer
Shots:
- Lumicell received US FDA approval for Lumisight (pegulicianine) & PMA for the Lumicell Direct Visualization System (DVS), collectively known as LumiSystem
- Lumisight and Lumicell DVS provide 84% diagnostic accuracy in detecting residual cancer during lumpectomy, potentially avoiding second surgeries
- The system’s safety was confirmed through data from over 700 breast cancer patients in five US clinical studies. Common side effects of LUMISIGHT include hypersensitivity and abnormal urine color, with potential serious reactions like anaphylaxis. Efficacy results from the INSITE trial were published in NEJM Evidence
Ref: Businesswire | Image: Lumicell
Related News:- Lumicell Reports the Submission of Premarket Approval Application to the US FDA for Lumicell Direct Visualization System
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
