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FDA clears OCT angiography module for Spectralis
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The FDA has issued 510(k) clearance to the OCT angiography module for new and existing Spectralis upgradeable diagnostic imaging devices, according to a press release from Heidelberg Engineering.
A noninvasive imaging technique that provides three-dimensional visualization of perfused ocular vasculature, OCTA is designed to give clinicians a more comprehensive understanding of ocular abnormalities, the release said.
“Our international experience with the Spectralis OCTA module has confirmed the significance of our live eye tracking and dynamic angiography to acquire clinically relevant data,” Ram Liebenthal, Heidelberg general manager, said in the release. “It also demonstrates our continued dedication to delivering high-resolution images, powerful clinical tools and a multimodal diagnostic approach to aid eye care professionals in the detection and management of diverse eye conditions, all on a single platform.”