Heidelberg receives FDA clearance to market Spectralis OCT glaucoma module
Click Here to Manage Email Alerts
Heidelberg Engineering received 510(k) clearance from the FDA to market the Spectralis OCT Glaucoma Module Premium Edition, which creates an anatomic map unique to each patient’s eye.
The module provides clinicians with objective and automatic measurement parameters for increased diagnostic accuracy, according to a company press release. It utilizes a new technology called Anatomic Positioning System, which uses the center of the fovea and the center of Bruch’s membrane opening to create an anatomic map of the eye. Each scan thereafter is automatically oriented according to each patient’s unique anatomic eye map.
In addition, the module compares a patient’s eyes to an age- and disc size-adjusted reference database of healthy eyes, noting small deviations that may be clinically relevant.