The US Food and Drug Administration (FDA) has granted 510(k) clearance to Heidelberg Engineering to market its Spectralis Optical Coherence Tomography (OCT) Glaucoma Module Premium Edition.
Heidelberg’s new module provides eye care professionals with a detailed analysis of the optic nerve head, retinal nerve fiber layer, and ganglion cell layer, using precisely matching scan patterns to the fine anatomic structures relevant in glaucoma diagnostics.
Heidelberg Engineering managing director Dr Gerhard Zinser said: “The 510(k) clearance of this product is great news for our company and also for glaucoma patients in the US.
“The Glaucoma Module Premium Edition is an excellent tool to assess glaucomatous damage based on a novel objective examination of the optic nerve head anatomy.”
By using an anatomic positioning system, the module will create an anatomic map unique to each patient’s eye, with the help of two fixed and structural landmarks, including center of the fovea and the center of Bruch’s membrane opening.
At a later stage, without human intervention all scan protocols are oriented according to each eye’s unique anatomic map, enabling precise assessment of relevant structures over time.
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The Spectralis OCT Glaucoma Module 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.
The module enables sensitive assessment of structural damage characteristic of glaucoma and a close monitoring of structural changes indicative of glaucomatous progression.
The company said that the physiological and technical premise of the new module is based on research collaborations between two groups led by Canada-based Dalhousie University’s Balwantray Chauhan and Claude Burgoyne of Devers Eye Institute, located in US.
Heidelberg Engineering is a Germany-based company which manufactures diagnostic instruments for eye care professionals.
Image: Eye scans from the SPECTRALIS OCT Glaucoma Module Premium Edition. Photo: courtesy of Business Wire.