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Wound Imaging Device

Handheld technology to visualize fluorescence in wounds1,2

PRESS RELEASE

MolecuLight Receives FDA 510(k) Clearance for its i:X® Handheld Fluorescence Imaging Device for Wound Management

New FDA Approval Extends Label to Including the i:X’s® Detection of Bacteria and Digital Wound Measurement

TORONTO, Canada – (December 5, 2019) MolecuLight Inc., the world’s leader in handheld fluorescence imaging for real-time visualization of fluorescence...

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Intended Use & Indication for Use

The MolecuLight i:X is intended for use as a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to:

(i)    View and digitally record images of a wound,

(ii)   Measure and digitally record the size of a wound, and

(iii)  View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light.

The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >104 CFU per gram as compared to examination of clinical signs and symptoms alone.

•  The MolecuLight i:X device should not be used to rule-out the presence of bacteria in a wound.

•  The MolecuLight i:X does not diagnose or treat skin wounds.