US-based Orlucent has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its Orlucent Skin Fluorescence Imaging System.

Orlucent Skin Fluorescence Imaging System is said to be a handheld point-of-care molecular-based imaging system.

The company has designed the system to noninvasively detect and clinically evaluate the presence of biological tissue remodelling activity related to the growth of atypical moles in adults.

It uses a topically applied tiny peptide fluorescent dye and handheld imager to non-invasively identify a biomarker of early tissue alterations and report the level of possible concern.

It is indicated for use by physicians along with the conventional clinical visual skin exam and data on the patient’s skin type and medical history.

According to the medical device maker, the in vivo molecular imaging system will support the development of a clinical course of action and identify melanoma at its very early phase.

Orlucent president Catherine Shachaf said: “We are excited the FDA has recognised the Orlucent system as a Breakthrough Device.

“It’s estimated that anywhere from 2% to 53% of US 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.”

Orlucent said that the healthcare professional administers the reagent and then uses the imager to take both white light and fluorescent images in order to use the system for evaluating an unusual lesion.

The images are analysed and displayed by the system’s image analysis software, which also assigns a probability score for the presence of tissue remodelling.

Doctors can use the Orlucent system’s score in conjunction with their clinical evaluation to decide whether to remove the mole and send it for biopsy or continue to observe the mole. They may also retest it with the imaging system in the future, the company added.