FDA Grants Fast Track Status, Rolling Review to Lumicell’s LUM Imaging System

FDA Grants Fast Track Status, Rolling Review to Lumicell’s LUM Imaging System
The U.S. Food and Drug Administration (FDA) has granted fast track designation with rolling review to Lumicell's LUM Imaging System for the detection and treatment of breast cancer. Fast track is given to accelerate the development and review of investigational therapies aimed at treating serious or life-threatening conditions, and addressing an unmet medical need. With this designation, Lumicell will now have the chance to engage in early and frequent interactions with the FDA to discuss the next steps in the regulatory review process for its imaging system. Additionally,  the technology company is planning to take advantage of the possibility of submitting a rolling review — another benefit that comes with fast track — to submit portions of a new drug application (NDA), a regulatory request for approval, for FDA review as soon as possible. With a rolling application, companies have the opportunity to submit NDA modules as soon as they are completed, rather than gathering all required clinical information before submitting their full and final NDA. According to Lumicell, this new fast track designation represents another important milestone in its cancer detection system’s path to approval. “The FDA’s decision to grant Fast Track Designation is an important step in bringing the Lumicell Imaging System closer to FDA approval and providing surgeons with this innovative technology to detect and remove cancerous tissue more confidently and efficiently than ever before,” Kevin Hershberger, president and CEO at Lumicell, said in a press release. The company’s LUM Imaging System was designed by engineers and scientists in collaboration with breast cancer specialists, and is specifically intended to allow surgeons to identify and remove residua
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