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# Melanoma Imaging Device Get Breakthrough Status
- URL: https://www.fdaweb.com/melanoma-imaging-device-get-breakthrough-status/
- Published: 2023-05-23T12:00:00.000Z
- Updated: 2026-09-14T18:33:45.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154515

FDA has granted Orlucent a breakthrough device designation for the company’s Orlucent Skin Fluorescence Imaging System, a handheld point-of-care molecular-based device designed to identify and clinically assess the presence of biological tissue remodeling activity associated with the development of atypical moles in adults. “The Orlucent system is designed to be used by physicians, in conjunction with traditional clinical visual skin examination as well as information on the patient's skin type and medical history, to help physicians determine a clinical course of action and identify melanoma at its very earliest stages,” the company says.

To use the device for assessing an atypical lesion, a healthcare professional can apply the reagent and then use the imager to capture both white light and fluorescent images, the company says. Its image analysis software is then used to analyze and display the images as well as to provide a probability score for the presence of “tissue remodeling,” it says. “A physician can use the Orlucent system's score along with their clinical assessment in determining if they should remove the mole and send it for biopsy or continue to observe the mole with the potential to retest it with the Orlucent system in the future.”