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BioWorld - Sunday, March 15, 2026
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Home » Orlucent receives breakthrough device designation for hand-held mole imaging system
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Orlucent receives breakthrough device designation for hand-held mole imaging system

June 1, 2023
By David Godkin
If Orlucent Inc. has its way atypical moles in adults will soon give up their secrets to clinicians on the lookout for skin cancer, this after the Los Gatos, Calif.-based company received a U.S. FDA breakthrough device designation for its non-invasive Orlucent skin fluorescence imaging system. The system is a hand-held point-of-care molecular-based imaging device that identifies “tissue remodeling activity” inside atypical moles that could be a precursor to early melanoma.
Medical technology Regulatory Diagnostics Cancer Dermatologic U.S. FDA

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