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Lumicell Reports the Submission of Premarket Approval Application to the US FDA for Lumicell Direct Visualization System

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Lumicell Reports the Submission of Premarket Approval Application to the US FDA for Lumicell Direct Visualization System

Shots:

  • The company has submitted the premarket approval application to the US FDA for Lumicell DVS to allow real assessment of the breast cavity for residual breast cancer detection & removal
  • The submission was based on results from ~700 patients with breast cancer across 5 clinical trials at top academic & regional community cancer centers. The safety and efficacy of the Lumicell DVS have been examined in the P-III trial (INSITE) in 406 patients at 14 sites & results will be presented at ASBrS 2023

Lumisight received the FTD from the US FDA & Lumicell DVS received BTD to identify residual cancer during the initial lumpectomy. Lumisight (pegulicianine) is intended for use with Lumicell DVS for fluorescence imaging of the lumpectomy cavity

Ref: BusinessWire | Image: Lumicell

Related News:- Lumicell Reports the NDA Submission of Lumisight Optical Imaging Agent to the US FDA for the Detection and Removal of Intraoperative Breast Cancer

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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