Location: Newton, MA
Press Release, Regulatory May 22, 2023 Lumicell Comment: 1

Lumicell Announces FDA Acceptance and Priority Review of New Drug Application for LUMISIGHT™ Optical Imaging Agent for Breast Cancer

NEWTON, Mass., May 22, 2023—Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for the LUMISIGHT™ Optical Imaging Agent and accepted the Premarket Approval (PMA) application for the Lumicell™ Direct Visualization System (DVS). The Lumicell DVS is an investigational system designed for...
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Press Release, Regulatory April 18, 2023 Lumicell Comments: 2

Lumicell Direct Visualization System Premarket Approval Application Submitted to U.S. FDA for Intraoperative Breast Cancer Detection and Removal

Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a Premarket Approval (PMA) application for its Lumicell™ Direct Visualization System (DVS) has been submitted to the U.S. Food and Drug Administration (FDA)....
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Press Release, Regulatory March 21, 2023 Lumicell Comments: 0

Lumicell Submits New Drug Application for LUMISIGHT™ Optical Imaging Agent to U.S. FDA for Intraoperative Breast Cancer Detection and Removal

Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a New Drug Application (NDA) for its LUMISIGHT™ Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA)....
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Press Release, Regulatory November 17, 2020 Lumicell Comments: 0

Lumicell Granted Fast Track Designation Approval by the FDA for Breast Cancer Treatment

Lumicell, Inc., an innovation leader in image guided cancer surgery, today announced it has received Fast Track designation with rolling review from the FDA Center for Drug Evaluation and Research (CDER) to expedite the development and review of the LUM Imaging System in the treatment of Breast Cancer....
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Clinical Studies, Press Release, Regulatory September 10, 2015 Lumicell Comments: 0

Lumicell Announces FDA Approval to Launch Feasibility Study in Gastrointestinal Cancers

Trial is funded by National Cancer Institute’s SPORE program Wellesley, Mass., September 10, 2015 – Lumicell, a leader in the field of image-guided cancer surgery, has received approval from the U.S. Food and Drug Administration (FDA) to launch a feasibility (pilot) study in gastrointestinal cancers. The study will focus on imaging tissue in patients with esophageal, colorectal and pancreatic cancers. The study will be conducted at Massachusetts General Hospital (MGH) and will be led by...
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Clinical Studies, Press Release, Regulatory May 20, 2015 Lumicell Comments: 0

Lumicell Announces FDA Approval to Launch Feasibility Study

Trial is funded by National Cancer Institute grant Wellesley, Mass., May 20, 2015 – Lumicell, a leader in the field of image-guided cancer surgery, has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to launch a feasibility (pilot) study for intraoperative imaging of breast cancer during surgery. The study will be conducted at Massachusetts General Hospital (MGH). Further trial information can be found here: https://clinicaltr...
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