Heidelberg Engineering wins FDA nod for upgraded eye imaging technology

Image of an eye using OCTA technology, courtesy of Heidelberg Engineering.

The FDA has approved Heidelberg Engineering’s optical coherence tomography angiography module (OCTA), the company said today. The module is available for new and existing Spectralis upgradeable diagnostic imaging devices used to manage diabetic retinopathy, age-related macular degeneration and other macular diseases.

OCTA is a noninvasive imaging technique that provides three-dimensional visualization of perfused ocular vasculature. Structural OCT uses light waves to take cross-section pictures of the retina, allowing the ophthalmologist to map and measure the thickness of each of the retina’s distinctive layers. Combined with dye-based angiography, the OCTA technology is designed to give clinicians a more comprehensive understanding of ocular abnormalities.

Since the original 510(k) clearance of OCT angiography, there have been significant advancements in the technology and specifically in its clinical applicability, making the validation of the technology a much more rigorous task, according to a statement from the company.

“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,” said Ram Liebenthal, general manager of the Franklin, Mass. company, in the statement. “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.”

“The addition of OCT angiography to Heidelberg’s Spectralis multimodal platform allows for the evaluation of retinal and choroidal vascular abnormalities in a noninvasive manner,” added Dr. Nadia Waheed, director of the Boston Image Reading Center and associate professor of ophthalmology at Tufts University School of Medicine in Boston. “I believe OCTA will soon become invaluable in our daily clinical routine for screening and diagnosing chorioretinal disorders.”

Heidelberg Engineering will provide training on the new technology.

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