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Orlucent Skin Fluorescence Imaging System Receives FDA Breakthrough Device Designation


The first-of-a-kind product uses a topically applied small peptide fluorescent dye and handheld imager to non-invasively detect a biomarker of early tissue changes.

The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Orlucent’s Skin Fluorescence Imaging System for the detection of suspicious moles.1 Orlucent’s device is a handheld point-of-care molecular-based imaging system designed to noninvasively detect and clinically assess the presence of biological tissue remodeling activity associated with the development of atypical moles in adults.

The handheld device can be used by health care professionals together with traditional clinical visual skin examinations, as well as the patient’s medical history and skin type. When used in conjunction with skin checks, the imaging device can help determine a clinical course of action and identify melanoma at its earliest stages.

To meet Breakthrough Device Designation qualifications of the FDA, the device must prove it “has the potential to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” Orlucent’s breakthrough designation will allow a quicker and more streamlined review pathway with the FDA to bring the imaging system to patients faster.

To use the imaging system on an atypical lesion, a health care professional applies the reagent and then uses the imager to capture both white light and fluorescent images. The device’s image analysis software analyzes and displays the images as well as provides a probability score for the presence of tissue remodeling.

A health care professional can use the mole imaging system’s score along with their clinical assessment to determine if they should remove a mole and send it biopsy, or continue to observe the mole with the potential to retest it with the Orlucentsystem later on.

Orlucent Skin Fluorescence Imaging System is an in vivo molecular imaging system and a first-of-a-kind device that uses a topically applied small peptide fluorescent dye and handheld imager to non-invasively detect a biomarker of early tissue changes and to report the level of potential concern for transition to melanoma.


  1. Orlucent receives FDA breakthrough device designation for handheld mole imaging system. Orlucent Inc. Published May 22, 2023. Accessed May 23, 2023. https://www.prnewswire.com/news-releases/orlucent-receives-fda-breakthrough-device-designation-for-handheld-mole-imaging-system-301829126.html
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