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Orlucent Receives FDA Breakthrough Device Designation for Handheld Mole Imaging System

May 22, 2023

Orlucent Logo

Orlucent, Inc., a company focused on clinical assessment of suspicious moles, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Orlucent® Skin Fluorescence Imaging System.

The Orlucent system is a handheld point-of-care molecular-based imaging system designed to noninvasively 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.

To qualify for the Breakthrough Device Designation, a device must show it has the potential to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The designation allows a collaborative and streamlined review pathway with FDA so the Orlucent technology can get to the market faster.

“We are excited the FDA has recognized the Orlucent system as a Breakthrough Device,” said Catherine Shachaf, Ph.D., president of Orlucent. “It’s estimated that anywhere from 2% to 53% of U.S. patients have moles that may be classified as suspicious, atypical, or dysplastic, and the Orlucent system will be an important tool to provide their physicians with information on a mole’s biological activity status as well as it’s potential to become melanoma.”

To use the Orlucent system for assessing an atypical lesion, a healthcare professional applies the reagent then uses the imager to capture both white light and fluorescent images. The system’s image analysis software is used to analyze and display the images as well as provide a probability score for the presence of tissue remodeling.

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.

For more information about the Orlucent System, please visit

About Orlucent
Orlucent, Inc. is developing the Orlucent® Skin Fluorescence Imaging System, an in vivo molecular imaging system. Between 2% and 53% of the US population have atypical/ dysplastic moles suspicious of becoming melanoma and the in-office Orlucent system will provide the physician with novel biological activity status as part of their clinical assessment. 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 and to report the level of potential concern for transition to melanoma.

See Full Press Release at the Source: Orlucent Receives FDA Breakthrough Device Designation for Handheld Mole Imaging System

Press Release by: Orlucent

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