Heidelberg Engineering has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SPECTRALIS® OCT Glaucoma Module Premium Edition.
The Glaucoma Module Premium Edition reportedly adds diagnostic capabilities to Heidelberg Engineering’s SPECTRALIS® OCT imaging platform, providing a comprehensive analysis of the optic nerve head, retinal nerve fiber layer, and ganglion cell layer by precisely matching unique scan patterns to the fine anatomic structures relevant in glaucoma diagnostics.
Using a new proprietary technology called the Anatomic Positioning System, the module reportedly creates an anatomic map unique to each patient’s eye. All subsequent scan protocols are automatically oriented according to each eye’s unique anatomic map, enabling a precise examination of relevant structures over time. Additionally, the Glaucoma Module Premium Edition compares patients’ eyes to an age- and disc size-adjusted reference database of healthy eyes representing the racial and ethnic mix of the US population, flagging small deviations that may be clinically relevant.
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Source: Heidelberg Engineering