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Lumicell shines a light on residual breast cancer with FDA approvals

Lumicell Inc. sees a brighter future now that it has secured U.S. FDA approval for both its new drug application for Lumisight (pegulicianine) optical imaging agent and premarket approval for the Lumicell direct visualization system . The company markets the two together as the Lumisystem to detect and resect residual breast cancer. Newton, Mass.-based Lumicell expects the Lumisystem will be available in the fourth quarter of 2024, Lumicell President and Chief Operating Officer Howard Hechler told BioWorld.

Howard hechlerLumicell incLumicell presidentChief operating officer howard hechlerHelmholtz diabetes centerCancer induced cachexiaPenx acipBioworld medtechLumicell incBreast cancer

FDA delivers approval to Lumicell s fluorescent system for highlighting residual breast cancer tissue

FDA delivers approval to Lumicell s fluorescent system for highlighting residual breast cancer tissue
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Howard hechlerMoungi bawendiMassachusetts institute of technologyAdministration of the lumisightDirect visualization systemMassachusetts instituteLester wolfe professorTarget laboratories

FDA Approves Drug-Device Combo to Detect Residual Cancer After Lumpectomy

The FDA has approved Lumisight (pegulicianine), an optical imaging agent, to illuminate residual breast cancer.

Howard hechlerDrug administrationLumicell direct visualization systemChief operating officer

Lumicell s Cutting-Edge Imaging Platform Receives Historic FDA Approval to Illuminate Residual Breast Cancer

Lumicell s Cutting-Edge Imaging Platform Receives Historic FDA Approval to Illuminate Residual Breast Cancer
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United statesBarbara smithJorge ferrerIrene wapnirHoward hechlerSociety of surgical oncologyStanford university school of medicineUs food drug administrationDepartment of breast surgical oncologyLumicell incMd anderson cancer centerProfessor of surgery at harvard medical schoolBreast program at massachusettsDrug administrationNew drug applicationPremarket approval

FDA Approves Lumisight and Lumicell DVS for Residual Breast Cancer Detection

The FDA has approved the optical imaging agent Lumisight and the Lumicell Direct Visualization System for use in fluorescence imaging in breast cancer.

Howard hechlerImaging drugs advisory committeeLumicell incLumicell direct visualization systemFluorescence guidanceBreast cancer lumpectomy